All posts by BIadmin

FDA Recommends “Modernizing” Review of Devices in Wake of Global Investigation

Jeanne Lenzer, The British Medical Journal: November 27, 2018


The US Food and Drug Administration is making changes to how medical devices are cleared for sale after a scathing investigation into the industry.

The global investigation into the medical device industry by journalists from 36 countries, including The BMJ, BBC Panorama, and the Guardian and led by the International Consortium of Investigative Journalists, unearthed thousands of documents to reveal rising numbers of malfunctions and injuries.

Scott Gottlieb, FDA commissioner, and Jeff Shuren, director of the Center of Devices and Radiological Health, said in a statement that there would be changes to the 510(k) pathway that is used to clear four in every five devices for sale. The pathway approves devices not on the basis of testing in humans but on how similar devices are to previous devices, called “predicates,” some of which were approved decades ago.

Gottlieb and Shuren said that … they were “encouraging” manufacturers to “use more modern predicates,” [….]

However, the reform didn’t go far enough, said Diana Zuckerman, epidemiologist and president of the National Center for Health Research in Washington, DC. She told The BMJ that using more “modern” predicates says nothing about safety or effectiveness. She said that “newer doesn’t mean better” and that “since less than 5% of 510(k) devices undergo any type of clinical trials, there’s no assurance that any devices cleared through that pathway are safe or effective.”

In 1996 the US Supreme Court concluded that “since the 510(k) process is focused on equivalence, not safety . . . if the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

A recent study found that 16% of mesh clearances were based on recalled devices. When the FDA was asked why it cleared mesh implants on the basis of predicate devices that had been withdrawn because of safety concerns, the agency said that it didn’t evaluate the performance of predicate devices when clearing devices for sale.

A study of high risk implanted cardiac devices found that only 5% underwent clinical testing that even partly approximated the testing required for drug approvals.

Nor is safety surveillance reliable. A Government Accountability Office analysis found that 99% of device related “adverse events” were never reported to the FDA and that the “more serious the event, the less likely it was to be reported.”

Read the original article here.

Will Medicare Pay to Remove My Breast Implants?


Medicare usually covers breast implant (saline or silicone) removal for any of these conditions:

  • Painful capsular contracture with disfigurement
  • Implant rupture
  • Infection
  • Implant extrusion (coming through the skin)
  • Interference with the diagnosis of breast cancer
  • Siliconoma or granuloma (silicone-filled lumps under the skin)

Medicare coverage can differ depending on the state where you live. You can check the specific Medicare policies on breast implants removal in your state here.

Whether or not Medicare will pay for your breast implant removal depends on many factors. Below are some questions that will help you figure this out.

Original Medicare Plan

Original Medicare means you’re enrolled in Medicare Parts A & B and don’t have a Medicare Advantage plan.

1) Is your surgeon a Medicare Participating Provider “who takes assignment?” If you aren’t sure, ask the surgeon’s office whether they “take assignment.”

  • A surgeon who “takes assignment” has agreed to accept the Medicare fee as full payment for the surgery. The surgeon must submit the claim for your surgery directly to Medicare. Your surgeon CANNOT charge you, except for the deductible and/or copay amounts that Medicare doesn’t cover. Your surgeon should call the Medicare provider line to see if your surgery will be covered.
  • Even if your surgeon doesn’t think Medicare will cover the surgery, you still should ask the surgeon’s office to call the Medicare provider line to check. Many surgeons don’t know that Medicare will cover breast implant removal, so it’s important to have them check.
  • A Medicare Participating Provider who takes assignment IS REQUIRED to submit your Medicare claim within a year of your surgery. If they don’t, Medicare won’t pay and the doctor might try to get the patient to pay. That isn’t fair, so don’t let that happen to you.
  • You can check for Medicare participating providers here.

2) Is the surgeon you are thinking of using a Medicare non-Participating Provider “who does NOT take assignment?”

  • A surgeon who “doesn’t take assignment” can charge you up to 115% of the Medicare-approved fee. You might be asked for full payment upfront (at the time the surgery is done).
  • A surgeon who does not usually “take assignment,” can do so on a case-by-case basis, so you should check to see if the surgeon is willing to “take assignment” from Medicare in your case.
  • A surgeon who doesn’t take assignment may not be able to submit your claim to Medicare. You should ask the surgeon’s office who will be responsible for filing your claim. If the surgeon agrees to file, you should check to make sure it is filed soon. IMPORTANT: If it is not filed within one year of your surgery, Medicare will NOT pay the claim and you may be liable for the entire amount.
  • If your surgeon won’t submit your claim to Medicare, you can fill out this form for reimbursement with Medicare.

3) Has the surgeon you plan to use “Opted Out” of Medicare?

  • Surgeons who have “opted out” of Medicare don’t take assignment, submit Medicare claims, or limit fees to the Medicare-approved fee amounts.
  • Surgeons who have “opted out” of Medicare are REQUIRED to notify the patient with a written contract. This contract confirms that a patient understands she is directly responsible for paying the surgeon whatever he or she charges and that she CANNOT seek reimbursement from Medicare.

4) Do you have a supplemental insurance plan in addition to your Medicare coverage?

  • A supplemental plan might cover the deductible and/or copay amounts.
  • Medicare is your primary insurance and will reimburse the surgeon. You will need to get approval from Medicare BEFORE going to your supplemental plan.

Medicare Advantage Plan

1) Are you enrolled in a Medicare Part C Advantage Plan?

2) Is your surgeon part of your Plan network? If you are unsure, ask your Plan.

Because Medicare Part C Advantage Plans deal with Medicare directly, you won’t have to submit a claim to Medicare.

If your surgeon is NOT in your Plan network of providers, you may have to submit a claim directly to your Plan, Your Plan may limit what they will pay for your surgery. IMPORTANT: To avoid unplanned expenses, check with your Plan BEFORE you schedule surgery with a surgeon who is outside your Plan network.

3) Does your Plan require that you get pre-approval for your surgery and, if so, have you received pre-approval?

Most plans require that you get permission from your Plan before the surgery. If you don’t get pre-approval, the Plan might not cover your surgery.

Are you on Medicare and Medicaid?

People who are enrolled in both Medicare and Medicaid are called “Dual Eligible Beneficiaries.” They are enrolled in Medicare Part A and/or Part B and receive full Medicaid benefits and assistance with Medicare premiums.

If you’re dual eligible, your medical services generally are usually paid at the Medicare-approved amount. Because it depends on your unique situation, you should speak to your primary care doctor about the specifics.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Private Insurance Help


Follow these steps to try to get insurance coverage for your breast implant removal:

1) Find Out Whether Your Insurance Company Considers Removal “Medically Necessary”

Insurance companies cover services that they determine to be “medically necessary” to treat a disease or illness. Although you or your doctor may believe a service is medically necessary, insurance companies don’t always agree.

Most insurance companies will not cover any cosmetic procedures and some will not cover complications from previous cosmetic procedures.  However, many companies consider removal of breast implants medically necessary for patients with any of these conditions:

Unfortunately, insurance companies usually won’t cover the cost of breast implant removal for autoimmune or connective tissue diseases or other systemic complications. If you have any of the conditions listed in the bullets above, you should focus on those in your insurance claim because insurance companies are more likely to cover these symptoms.

How do I know whether my insurance company will cover the cost of removal?

To find out if your insurance company is likely to cover removal, you will need to look at your specific policy language. You can usually find this language in a document called “Evidence of Coverage” (EOC). It is a document (and is often quite lengthy!) that describes in detail the healthcare benefits covered by your health plan, including procedures that your insurance company will and will not cover.

You can access an electronic copy of your EOC through your online account on your insurance company’s website. You can also call the member services number on the back of your insurance card and ask an insurance representative for a copy of this document.  

What Do I Look For?

Once you have your policy, look for language about breast implant removal.  If you don’t see any language about breast implant removal, search for language on cosmetic surgery. If you cannot find any specific language about breast implant removal, you should also look to see what your insurance company’s definition of “medically necessary” is. It is also important to check whether your insurance plan requires pre-authorization for any surgeries.

If you’re using an electronic copy, you don’t need to read the entire document. You can easily find terms using the “Control+F” keys on your keyboard. That will provide a “search box” that will search for any words you enter. Just enter the word “implant” or “cosmetic” or “silicone” in the search box. If you are unable to find what you need in the lengthy document, call your member services line and ask for assistance to locate the correct pages.

2) File for Pre-Authorization

Most insurance companies will require that you get pre-authorization (also called prior approval or pre-certification) before the surgery. This means your insurance company reviews your relevant information and determines whether surgery is medically necessary. Then, the insurance company will let you know if it is likely to cover your surgery. However, that pre-authorization isn’t a promise that your surgery will be covered.

The easiest way to get pre-authorization is to have your plastic surgeon sign and submit a letter that lists your symptoms and explains why removal is medically necessary based on your insurance policy language. (Usually one or more of health problems listed on the bullets earlier in this article). Your surgeon should also enclose any medical documentation that provides proof of your symptoms. 

It is best if your plastic surgeon signs this letter to send with your insurance claim. However, if your surgeon is unwilling to sign the letter, another doctor involved with your care, such as your primary care provider, can sign. You can find templates for these letters here. If your doctor agrees to sign the letter, but won’t submit it to your insurance company, you will need to submit the letter before your surgery to ensure you receive pre-authorization.

NOTE: If you don’t get pre-authorization when it was required, the insurance company isn’t required to cover the surgery, even if it considers the procedure to be medically necessary.

3) After Your Surgery: Filing a Claim

If your surgeon is in your insurance company network, he/she should file a claim on your behalf. If not, you will need to file the reimbursement claim with your insurance company. If you didn’t seek pre-authorization before your surgery, you can still file a reimbursement claim.  You will need to submit your pre- and post-operative reports, along with a letter from the surgeon stating that the procedure was medically necessary. However, as we stated above, if your insurance company requires pre-authorization, it is unlikely that they will reimburse you for your surgery, even if your surgery was medically necessary. Therefore, we suggest that you file a pre-authorization claim to improve your chances of getting insurance coverage.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

After Years of Complaints, U.S. and U.K. Officials Say They Want to Reform the Medical Device Industry

Amy Martyn, Consumer Affairs: November 29, 2018.

The official who oversees medical device safety for the Food and Drug Administration (FDA) recently said he wants the United States to be the “first” to approve medical devices, raising concerns among public health advocates that the agency isn’t taking efforts to reform the device industry seriously enough.

Dr. Jeffrey Shuren, the director of the FDA’s medical devices division under both the Obama and Trump administrations, earlier this year agreed to speak at a conference attended by medical device executives, according to a new report by the Associated Press.

At the conference, which cost executives $1,000 a head to attend, Shuren reportedly said that the FDA’s goal was to be “first in the world” to approve new devices. He also said he wanted the agency to remove “unnecessary burdens” for companies hoping to get their devices approved.

Such a goal may be at odds with what public health advocates say is a need to reform medical device regulation. Dr. Peter Lurie, a former FDA official who now heads the watchdog the Center for Science in the Public Interest, told the Associated Press that Shuren’s comments essentially offered device executives “an invitation to a race to the bottom for scientific standards.”

“Fatally flawed” system

The medical device industry already faces lower barriers for approval than the drug industry does, despite the fact that many medical devices are intended to be permanent implants or can leave lifelong impacts on a person’s body.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” Dr. Diana Zuckerman, a health policy analyst and head of the National Center of Health Research, told ConsumerAffairs earlier this year.

Independent researchers for years have said that the medical device approval process in the U.S. is “fatally flawed.”

More recently, a Netflix documentary called The Bleeding Edge exposed the tragic, life-long effects that four failed medical implants had on nearly 70 patients interviewed for the film.

Looking for improvement

Regulators in the United States and abroad are now promising to put safety at the forefront of medical device regulation.

Shortly before Thanksgiving, FDA Commissioner Scott Gottlieb, who was portrayed in the Netflix film as being in the industry’s pocket, announced new plans for the agency to “create a more robust medical device safety net for patients through better data.”

A similar call to reform medical device regulations is also currently taking place in Europe. In the United Kingdom, the Royal College Of Surgeons recently called for “drastic regulatory changes” after an investigative report by a group of European journalists published yesterday linked 83,000 deaths and 1.7 million injuries to faulty medical devices.

But while medical devices face low scrutiny from European regulators, the socialized healthcare systems abroad are at least more hesitant about allowing such devices to actually be used in surgery, experts say.

“In Europe, it’s very easy to get something on the market, but the national health plans won’t pay for it if it’s not proven to be safe and effective,” Zuckerman of the National Center for Health Research previously told ConsumerAffairs.

It’s not that Europeans aren’t reporting injuries from faulty devices. However, those who do tend to be wealthier people who opted for private insurance over the public plans.

See the original story here.

Here’s What We Know About Breast Implants and This Rare Type of Cancer

Daisy Melamed Sanders, Survivornet: November 2018.

 

A series of new stories are examining the potential health risks that both silicone- and saline-filled breast implants may carry. The most serious of these is the possibility of developing a type of blood cancer. What’s not yet clear is if the evidence is significant enough for the government to issue a warning.

The blood cancer that implants may cause, called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of non-Hodgkins lymphoma that is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.

And while getting breast implants certainly does not definitively mean you’ll definitely get this type of lymphoma, it’s a dangerous illness for those who do get it. “ALCL is rare, but for those who get ALCL from their breast implants, it is very frightening and potentially fatal,” says Diana Zuckerman, PhD, President of the National Center for Health Research.

Here’s what we do know: The Food and Drug Administration—responsible for regulating medications and medical devices—has acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011. The risk involves both textured and smooth implants but the FDA’s position is that the textured kind may have a higher likelihood of causing the disease. The FDA also notes that incomplete or inefficient monitoring of, and reporting on, these health issues on a national level has meant that many women do not know all the facts when choosing to have implants for either cosmetic or reconstructive reasons.

According to the FDA, “In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. Precise risks are difficult to determine due to lack of information about how many patients have received breast implants in the US and worldwide.”

In an interview conducted prior to recent news, Dr. Andrea Pusic, Chief of Plastic Surgery at Brigham and Women’s Hospital, told SurvivorNet that breast implants are generally considered safe—but they do require monitoring by a doctor. The FDA also states that breast implants are “not lifetime devices,” and that the longer a patient has them, the more likely they are to rupture or experience other complications.

With regards to the safety of implants, Dr. Darrick Antell, a private practice plastic surgeon in New York City, cites the rarity of these instances as part of the reason implants are not excessively dangerous. “Textured surface implants have rarely been noted to develop ALCL, at a rate of 1 in 30,000—I would even recommend them to a family member,” he says. “Multiple leading institutions from around the world have shown them to be safe.”

But, as Dr. Zuckerman urges, it’s important to discuss the risk with your doctor before getting implants, because some women felt blindsided and uninformed about the disease possibility. “We know women who, when they developed ALCL, felt betrayed because their doctors hadn’t warned them of the risks.”

Breast implants also have the possibility of causing other health or physical issues. These issues have not been fully studied, but Zuckerman and the NCHR recently released a paper that discusses some of the possible side effects.

The risks that come with implants are real for all women, Dr. Zuckerman tells SurvivorNet, but these risks increase with a personal or family history of autoimmune or connective tissue symptoms or diseases. They can happen soon after getting implants or years later, and are especially likely when a silicone gel implant breaks—most likely after three years. Another issue is that leaking silicone can migrate into the lymph nodes, and, “from there, the silicone can get into the lungs, liver, or other organs.” Broken saline implants, she continues, offer less risk when they leak, but can cause health issues from the silicone shell, other chemicals, as well as from bacteria, fungus and mold issues that develop over time.

This isn’t the first time instance of concern regarding breast implants and potential health risks. Throughout the 1980’s and early 1990’s, a company called Dow Corning was named in a number of class-action lawsuits claiming that their breast implants were the cause of a number of health issues.

In 1992, the FDA mandated that silicone implants be removed from the market, but they were re-introduced in 2006 following stricter regulations around tracking patients for at least 10 years after their surgeries. However, because monitoring the implants and patients with them is not always thorough nor properly reported, it is difficult to know for sure what side effects implants are having in the long term.

The best idea, as always, is to discuss all the possible risks and benefits of implants with your doctor before any procedures, and be on alert for any symptoms that indicate a medical issue, suggests Dr. Zuckerman. “If a woman with implants starts to have any of the autoimmune symptoms that we’ve described in our report, she should consider having her implants removed.”

See the original story here.

US Goal to be “First” on Devices Worries Former Regulators

Matthew Perrone, Associated Press: November 27, 2018

WASHINGTON (AP) — Dr. Jeffrey Shuren was adamant: The United States would never cut corners to fast-track the approval of medical devices.

“We don’t use our people as guinea pigs in the U.S.,” Shuren said, holding firm as the new director of the U.S. Food and Drug Administration’s medical devices division.

Again and again in 2011 — four times in all — Shuren was summoned before Congress. Lawmakers accused the agency of being too slow and too demanding in reviewing new devices like heart valves and spinal implants, driving U.S. manufacturers overseas where products faced less rigorous review. Each time, he pushed back.

And yet the next year, Shuren and his team adopted an approach that surprised even some of his closest colleagues: The FDA would strive to be “first in the world” to approve devices it considered important to public health.

The agency’s shift mirrored the talking points of the $400 billion medical device industry — a lobbying behemoth on Capitol Hill — and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.

Under Shuren, annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and quality issues have fallen roughly 80 percent, an Associated Press investigation found.

The assortment of medical devices now on the market includes spinal rods that can leave metal shards in children and a nerve-zapping obesity implant that may not work for many patients.

The cheaper and faster medical device approvals began despite multiple, high-profile safety problems involving pelvic mesh, hip replacements and other implants.

An AP analysis of FDA data shows that since 2012, tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing. The FDA’s database for reporting device problems often includes incomplete, unverified information submitted by manufacturers, physicians, lawyers and patients. Because of these limitations, it’s often unclear whether a device played any role in an injury or death.

In response to questions from the AP, the FDA said its “first in the world” goal was not about a competition with other countries but rather was adopted as part of a strategy that also focused on quickly identifying defective products to ensure U.S. devices “remain safe, effective and of high quality.”

The agency said it has focused on taking steps to reduce the time and cost of device development “that do not compromise our standard of reasonable assurance of safety and effectiveness.”

Warning letters have declined, the FDA said, because the agency is using a new approach that involves fewer warnings but more inspections to oversee companies that violate its rules.

Last week, the FDA announced a new goal to be “consistently first” among the world’s regulatory agencies to identify and address medical device safety issues.

The agency also rejected the idea that Shuren’s approach to regulation has changed over time, saying he has worked for years to improve patient safety.

Still, some current and former FDA officials are worried about the ambition to be first on approvals. They include Dr. Peter Lurie, who calls the agency’s new direction “an invitation to a race to the bottom for scientific standards” seemingly prompted by industry pressure. Lurie held senior posts at FDA from 2009 to 2017 and now heads the nonprofit Center for Science in the Public Interest.

The FDA’s medical device standards are still considered among the highest in the world, requiring “reasonable assurance” of both safety and effectiveness. But by trying to outpace countries with less stringent requirements, Lurie said, the FDA has opened the door to lowering its own standards to achieve its goal.

The FDA’s struggle to find the right mix of regulation and innovation in overseeing more than 190,000 medical devices — from pacemakers to contact lenses to surgical robots — has been chronicled for decades by government inspectors and outside researchers.

For almost as long, the agency has had a symbiotic relationship with industry.

Fees paid by medical device manufacturers for the review of their products now cover about 35 percent of the annual budget of the agency’s Center for Devices and Radiological Health. The last four officials in Shuren’s position have gone on to higher-paid positions in industry.

In addition, Shuren’s wife, Allison, is a former lobbyist who now leads her law firm’s health-care practice group and advises medical device clients, among others, on regulatory and legislative issues. The FDA said Shuren passed a “rigorous ethics review process” before assuming his position that addressed potential conflicts of interest. He also recuses himself from FDA matters involving clients represented by his wife or her firm, the agency said.

Joshua Sharfstein, a former FDA deputy commissioner now teaching at Johns Hopkins University, praised Shuren for balancing the competing demands of protecting the public while promptly approving beneficial new devices.

“I don’t think there’s a viable way to be the head of devices and be in open warfare with industry all the time,” he said.

But some who spent years working under Shuren say speeding up product reviews became the clear priority after 2012.

“Basically, it was ‘We need to find ways to get products on the market quicker, faster and we need to figure out how to reduce the premarket data requirements,’” said Christy Foreman, an industry consultant who spent 22 years at the FDA, including four years leading its device review office.

The FDA notes that laws passed by Congress require the agency to emphasize the “least burdensome approach” to reviewing new devices. But the agency itself helped fashion those laws, working with industry lobbyists and lawmakers on provisions that effectively limit its ability to request additional evidence from manufacturers.

The philosophy of “acceptable uncertainty” is sometimes the price of making life-saving devices quickly available, according to the FDA. At the same time, it acknowledges its main system for tracking problems is riddled with “incomplete, inaccurate, untimely, unverified or biased data.”

“So instead, you have devices of unknown benefit on the market that still harm patients,” said Dr. Rita Redberg, a prominent medical researcher and cardiologist at the University of California San Francisco. “I do feel that the FDA sees their role as making industry happy and not as much protecting the public health.”

___

Every day, patients in the U.S. and around the world benefit from medical technology. The inventions of this global industry include implants that help the deaf hear, implantable lenses that restore sight to the elderly and cardiac pumps that keep failing hearts beating.

For most of the last century, medical devices were not regulated in the U.S. But a series of high-profile safety problems in the 1970s — including deaths, miscarriages and injuries caused by a contraceptive implant — pushed Congress to intervene.

The laws that resulted are both more complex and less demanding than those governing drugs.

To win FDA approval, for example, most new prescription drugs undergo two large, rigorous clinical studies proving they benefit patients. But most new medical devices enter the market with no clinical trial testing.

Historically, more than 95 percent of FDA-reviewed devices on the market went through a streamlined process in which they need only show that they are “substantially equivalent” to a product already on the market. Typically, only devices considered high-risk, like heart pumps, must demonstrate safety and effectiveness in humans, but even those can sometimes rely on existing scientific data as opposed to new studies.

On Monday, the FDA proposed changes to the streamlined system that would push manufacturers to incorporate more up-to-date technology into their devices. But some of the major reforms could take years to implement.

Some experts have long argued that this fast-track pathway was never intended to be permanent. As framed by Congress in 1976, the system was originally meant to be a temporary way to grandfather in thousands of devices already on the market that weren’t considered high-enough risk to require immediate review. But instead of being phased out, it became mainstream.

The industry contends that flexibility is critical to innovation, allowing manufacturers to quickly and cheaply experiment and improve. An FDA review under that process costs about $11,000, compared to $320,000, under the more rigorous standard.

The result, though, is that some medical products barely resemble the decades-old “predicates” they reference in applying for FDA clearance. And even when old devices have been linked to injuries or death, future products are allowed to reference them for approval because the FDA lacks explicit legal authority to swiftly intervene.

In more than four decades, the FDA has banned only two products — powdered surgical gloves, which caused allergic reactions in patients, and fake hair implants, which caused infections and didn’t work. The agency says its ability to ban products is “bound by federal law” and is essentially limited to devices that are either deceptively marketed or unreasonably dangerous.

The U.S. device system is “basically set up to get things on the market, not to get things off the market,” said Larry Kessler, a University of Washington professor and consultant who worked more than a decade in the FDA’s device center.

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A device used to treat childhood scoliosis illustrates how quickly manufacturers can win FDA approval with minimal clinical trial testing.

The MAGEC rod uses remote-controlled magnets to gradually extend titanium columns implanted in children’s backs to correct debilitating spinal curvature. It is marketed as an alternative to traditional implants, which require frequent surgeries to manually extend the rods as a child grows.

Prior to clearing it for use in the United States, the FDA allowed the MAGEC rod’s California-based manufacturer, Ellipse, to begin exporting its product overseas.

The company enlisted a Hong Kong surgeon to conduct its first human trials after winning European approval in 2009 following experiments in pigs. In a company-funded study published three years later — based on the results of just two patients — the surgeon concluded the MAGEC rod “improves quality of life and is more cost-effective.” The rods were later implanted in patients in Australia, Israel, Korea and elsewhere.

The company had assumed it would need to conduct a large clinical study including American children to win FDA approval for use in the United States, Dr. Behrooz Akbarnia, a San Diego-based surgeon and company consultant, said in an interview.

But in early 2014, the FDA informed the company it could seek approval via the streamlined process, Akbarnia said. Ellipse claimed its device was “substantially equivalent” to a mechanical implant developed in the 1950s. It was cleared for use in the U.S. by the FDA in just 35 days.

“That was one of the things that surprised me,” Akbarnia said, “because it was so fast.”

The approval also “shocked the spine industry,” according to an article by Ellipse’s former vice president of engineering Tiger Buford, who did not respond to repeated requests for an interview.

More than 2,000 children have been implanted with MAGEC rods worldwide, according to company filings by Ellipse, which was purchased by Nuvasive in 2016 for roughly $400 million.

Anthony Wainess was 9 when he became the first U.S. child to have MAGEC rods implanted in 2013 under a “compassionate use” exemption by the FDA. The rods temporarily helped the boy’s spine grow correctly, but began breaking within a year and were removed in 2016.

Anthony’s doctors theorized his body might be having an allergic reaction to the metal rods, according to his father, Steven Wainess.

The FDA told the AP that the MAGEC rod was cleared based on laboratory testing, animal studies and a clinical study “to demonstrate the device is safe and effective.”

The agency said it requires makers of all spinal implants to include warnings about potential risks, noting that the MAGEC rod’s labeling warns that it can break, move, corrode, cause pain and should not be used by patients with metal allergies.

Researchers in Europe have identified cases of metallosis in children with the rods, the tissue around their spines stained black by titanium shards and debris.

The long-term effects of titanium metallosis are not yet known, but metal debris in patients with chrome and cobalt hip implants can cause bone and tissue damage. The all-metal hip implants, also cleared through the FDA’s streamlined path to market, were implanted in an estimated 500,000 Americans before the FDA reclassified them as high-risk in 2016. Today, they have largely been recalled or phased out.

In a paper published in January in the medical journal, Spine, British orthopedic engineer Thomas Joyce said all 34 MAGEC rods examined by his lab at Newcastle University showed signs of metal wear, which could lead to debris spreading throughout children’s bodies.

The level of metal debris from MAGEC rods is about 100 times the levels he’d previously seen with hip implants, “a shocking amount,” he reported. Joyce has worked as an expert witness for lawyers suing metal hip makers. He donates his payment to his employer, per university rules.

Nuvasive said in a statement that its device has been shown to be effective in helping avoid the “pain, elevated complication rates, and psychological distress” of traditional spinal rods.

“While no technology in these patients is without risk, we have also seen MAGEC rebuild patient and family lives,” the company said.

Joyce said Nuvasive initially cooperated with his research, providing materials to help with his tests. But after his research was published, he said the company sent a letter to spine doctors worldwide questioning its validity.

Joyce said he’s simply trying to answer basic safety questions that haven’t been addressed by the company or regulators: Why does the MAGEC rod cause metallosis, and what are the long-term effects on children?

A device that claims to treat depression by beaming rapid-fire bursts of magnetic energy into the brain’s prefrontal cortex had a similarly smooth path to market, even though its benefits were unclear.

Between 2012 and 2016, former U.S. military members participated in a Department of Veterans Affairs study of the transcranial magnetic stimulation device, or TMS. As of 2018, the VA has spent more than $3.4 million acquiring dozens of the machines and related supplies, based on the FDA’s approval.

The FDA cleared TMS technology for the U.S. market in 2008 even though the agency’s own advisers said data submitted by the original manufacturer failed to establish its effectiveness. In fact, the advisers called its effect “marginal,” ?borderline” and “questionable.”

The experts did note that TMS therapy appeared “reasonably safe,” producing only minor complications such as headaches and scalp pain. That compared favorably to older devices used for hard-to-treat depression, including electro-shock therapy.

The FDA eventually approved the device through a pathway reserved for “low to moderate” risk devices that are not equivalent to previously approved devices.

Under Shuren’s tenure, six more TMS manufacturers have come on the market, mainly by piggy-backing off the original FDA clearance.

This June, when the VA published the findings of its study , they echoed the results of a decade earlier: TMS made almost no difference in patients’ depression. The authors offered several explanations, including that veterans often have multiple psychiatric problems that complicate treatment.

The American Psychiatric Association’s guidelines describe TMS as offering “relatively small to moderate benefits.” And even when TMS treatment is successful, its long-term durability has not been established in rigorous patient studies.

Still, with persistent marketing from manufacturers, TMS has gradually won acceptance as an alternative to antidepressants. Some clinics also advertise unapproved uses of the device, including for autism, Alzheimer’s and post-traumatic stress disorder.

More than 800 U.S. clinics have the devices, according to a filing from the original TMS manufacturer, Neuronetics Inc. The firm tells doctors they can recoup the cost of a machine by treating just 12 patients, with a typical course of treatment costing up to $10,000 for 30 or more sessions over four to six weeks.

“The clinics are proliferating, the insurance is reimbursing, but we still don’t exactly know what kind of patients should be receiving this intervention,” said Dr. Dost Ongur, a Harvard Medical School psychiatrist and editor of the journal that published the VA study.

TMS can be effective for certain patients, Ongur and other psychiatrists say, but identifying them can be challenging.

The FDA said it approved TMS after determining that its benefits outweighed its risks. The device’s approval is limited to patients who have failed to respond to drug therapy with at least one antidepressant, the agency noted.

Neuronetics said in a statement that its device has been proven effective in studies of more than 900 patients and is covered by more than 65 private insurers and the government’s Medicare plan. And Magventure, which makes the device used in the VA study, said TMS’ impact on the brain is “a well-established fact,” though researchers are still exploring the “optimal way” to treat different patient types.

But skeptics remain. The Blue Cross Blue Shield network’s unit for reviewing medical devices has assessed TMS three times, most recently concluding in 2014 that the studies “do not provide convincing evidence.” The group is considered a pioneer in evaluating medical technology.

Foreman, the former FDA review chief, said the “least burdensome” requirements that bind FDA reviewers make it difficult to demand better evidence for devices like TMS. In such cases, the agency’s position is generally “the device isn’t going to hurt anybody so let’s put it out there and let the consumer use it,” she said.

But even ineffective treatments for depression can be harmful, according to Diana Zuckerman, a depression researcher and president of the nonprofit National Center for Health Research, which assesses the quality of outside research and conducts its own.

“If you are going five days a week for a month, spending all this money and you feel you’re no better than when you started, you could end up more depressed,” Zuckerman says.

A new analysis of the TMS literature by Zuckerman’s group concludes that the treatment “is not shown to be beneficial compared to typical placebo effects.”

___

One of the rationales FDA cites for accepting uncertainty in new device safety and effectiveness is “patient preference,” which holds that the agency should consider patient opinions in its approval decisions.

Former FDA regulators say Shuren has repurposed that idea to justify putting even more devices on the market.

“Jeff tells wonderful stories in terms of ‘We’re doing this to make sure patients have this greatly improved technology,’” Foreman said. “But there’s another side to it, too.”

In recent years, patient preference information has been used to push approvals through the FDA’s pathway for high-risk devices, even in a case where the manufacturer failed to meet its own study goal.

In early 2015, the FDA approved a first-of-a-kind obesity device — an implantable stimulator that shoots electricity through the nerves connecting the stomach and brain. But less than a year earlier, the Maestro Rechargeable System had received a mixed review from the agency’s scientists and outside advisers.

To demonstrate effectiveness, the FDA and the manufacturer agreed Maestro patients would need to lose at least 10 percent more excess body weight than patients who received a sham treatment. But one-year data showed patients with the device lost only 8.5 percent more of their weight.

FDA scientists cautioned that long-term complications from removing and adjusting the device were not known. And some agency advisers said the demographic of study participants was unacceptable, since 93 percent were white and U.S. obesity rates are highest in African-Americans and Hispanics.

Still, the agency approved the device, citing a survey that showed patients were willing to accept the risks.

The patient survey, for which the FDA paid $280,000, is being used by regulators to “define minimum clinical effectiveness to evaluate new weight-loss devices,” the agency said, adding, “The FDA recognized obesity as an area of unmet patient need.”

The device manufacturer, ReShape Lifesciences, did not respond to requests for comment.

Earlier this year, Shuren addressed a conference of medical device industry executives, each of whom paid about $1,000 to attend.

Armed with dozens of PowerPoint slides, he explained how the FDA was approving more new devices in less time and credited his “north star” — the FDA’s goal to be “first in the world” to approve new devices.

He highlighted the agency’s new focus on “customer service,” including removing “unnecessary burdens” for companies and streamlining clinical trials.

“We all know that premarket clinical trials can be very costly, very time-consuming and, in some respects, of limited value,” Shuren said.

He explained that the FDA was now using easier-to-produce data to approve a variety of devices, including artery-opening stents, spinal implants and diagnostic tests.

Meanwhile, warning letters to device makers over safety, marketing and other issues have fallen to their lowest level in over a decade. The FDA says it has offset warnings with increased inspections and that companies continue to fix their violations at the same rate.

The stepped-up approvals and modified enforcement have the endorsement of President Donald Trump and his appointee, FDA Commissioner Dr. Scott Gottlieb, who has highlighted “acceptable uncertainty” as a key concept to “modernize” device regulation.

In September, the FDA began codifying that concept in draft guidelines for manufacturers, which would ease pre-market testing standards for certain devices, in exchange for companies conducting larger follow-up studies, even though the FDA’s own data show that many studies are not completed until five or more years after approval.

The FDA said in a statement that all devices carry a level of uncertainty, even after extensive testing. It said its guidance focuses on “breakthrough” devices, where “it may be appropriate to accept a little more uncertainty,” while still meeting FDA standards.

Lurie and other former regulators worry that the FDA is laying the groundwork for a “sliding scale” of medical evidence that will leave patients even more uncertain about the safety and effectiveness of devices.

“This guidance is basically a ‘come hither’ to industry, inviting them to ask FDA for the lower standards of evidence,” he said.

See original article here.

Breast Implant Illnesses: What’s the Evidence?

Diana Zuckerman, PhD, & Varuna Srinivasan, MBBS, MPH: National Center for Health Research.

Download the full article here.

Table of Contents

Introduction
Women Requesting Financial Help to Remove Implants
The Role of the Food and Drug Administration (FDA)
Breast Implant Design Innovations
Frequency of Loacal Complications
Cancers, Lymphoma, and Lung Disease
The Main Controversy: Autoimmune, Connective Tissue Disease, and Breast Implant Illness
Does Research Prove that Breast Implants Cause These Diseases?
Cohort Studies in the Meta-Analysis
Case-Control or Cross-Sectional Studies in the Meta-Analysis
Additional Studies in the IOM Report
Conclusions
References

 

Introduction

More than 400,000 women and teenagers undergo breast implant augmentation surgeries every year, with 75% for augmentation of healthy breasts and 25% for reconstruction after mastectomy.1 The popularity of breast implants has risen dramatically in the last 20 years and has more than tripled since 1997.2   The increase in breast implant surgery, however, does not necessarily reflect a similarly dramatic increase in the number of women with breast implants.  Many women who undergo surgery are replacing old implants that have broken or caused problems, and those replacements can occur every 10-15 years or more.

Debate swirls over the risks of breast implants, and physicians and patients are justifiably confused by the conflicting information available.  As concerns about breast implant safety die down, new controversies arise.  For example, in 2011, the FDA announced that breast implants might cause a rare type of lymphoma called ALCL, an international scandal revealed that tens of thousands of breast implants had been made with industrial silicone instead of medical grade silicone,3,4 and the FDA issued a report reassuring women that the high complication rate for breast implants was no higher than expected.  FDA discussion of complications then and now focuses on breast pain or hardness (called capsular contracture), implant rupture, and cosmetic problems in the breast area. The FDA has repeatedly reassured the public that studies “do not show evidence that silicone gel-filled breast implants cause connective tissue disease or reproductive problems”5 and that “the FDA does not have evidence suggesting breast implants are associated with health conditions such as “chronic fatigue, cognitive issues and muscle pain.”6

By 2018, there were more than 50,000 women reporting a range of symptoms they refer to as “breast implant illness” on two Facebook pages: Breast Implant Illness and Healing and Breast Implant Victim Advocacy.  More than a dozen Administrators and patient advocates from these two Facebook pages met with FDA officials in September 2018 to discuss their health issues and to urge the FDA to do more to require the completion of large, long-term scientific studies and to better inform women of the health problems experienced by many women as a result of their breast implants.

Women Requesting Financial Help to Remove Implants

Since 2015, the National Center for Health Research has been contacted by more than 4,500 women who had breast implants that they wanted to remove because of rupture, breast pain, or medical symptoms that they believed to be related to their implants.  Most of the women could not afford explant surgery, and asked for NCHR’s assistance in persuading their health insurance, Medicare, or Medicaid to cover the cost of implant removal without replacement.  NCHR has a project to assist these women if they have insurance but have had difficulty getting coverage for explant surgery.  Most health insurance policies will cover the cost of breast implant removal when it meets the policy’s criteria for medical necessity.  In almost all cases, medical necessity is defined as a leaking silicone gel breast implant or severe capsular contracture that causes breast hardness and pain.  We are not aware of any policies that will cover removal due to systemic illnesses caused by implants, such as those described by thousands of women with breast implants.  However, in many cases women have systemic illness in addition to having capsular contracture and a leaking silicone gel implant.

In November 2018, the Center began a ground-breaking study of more than 300 of the women who were able to get their implants removed.  The women were asked to list the most important reasons why they wanted to have their implants removed and not replaced.  Our preliminary analysis indicates that fewer than one-third had ruptured implants, approximately one half had breast pain, and 84% cited an array of other health issues that can be categorized as autoimmune or connective tissue symptoms, rather than diagnosed diseases.

At the time that their implants were removed, approximately three out of five of the women had implants in their body for 10 years or more, and many had these symptoms for years.  After having their implants removed, 89% of the women reported that their symptoms improved.

It is important to note that when implant manufacturers submitted studies to the FDA that were used as the basis of FDA approval, the companies stated that they intentionally excluded women with a history of autoimmune diseases.  FDA required that patient booklets provided by implant manufacturers must warn about that; For example, Allergan’s booklet states: “Caution: Notify your doctor if you have any of the following conditions, as the risks of breast implant surgery may be higher: “Autoimmune Diseases (for example, lupus and scleroderma).”7  Unfortunately, patients report they are not given the booklets or the warning prior to surgery, the FDA does not include that warning on its website, and in our preliminary analysis, 6% of the women in our study reported that they had been diagnosed with an autoimmune disease prior to getting implants.

The goal of this report is to consider all the research evidence to determine what is known and not known about the risks of breast implants, scrutinizing the research that has been conducted.  We will start with a summary of the role of the FDA and the less controversial issues regarding local complications from breast implants, and then focus on the most controversial issues: The strengths and weaknesses of the key studies that have been repeatedly quoted as evidence that breast implants do not cause autoimmune or connective tissue health problems.  We will also use the information gathered in NCHR’s preliminary study of women with implant problems to help understand the conflicting evidence of published studies.

The Role of the Food and Drug Administration (FDA)

Breast implants were first sold in the 1960s, but the FDA did not have the authority to regulate medical devices until 1976.  The 1976 law created three categories of medical devices based on risk, with Class III defined as high risk.  Breast implants were “grandfathered” onto the market, but by the late 1970’s, many doctors and scientists had expressed concerns about their safety.8  In 1978, an FDA Advisory Panel proposed that breast implants be categorized as moderate-risk Class II devices, which would not require any clinical trials proving safety or effectiveness for new implants to go on the market.  The FDA instead proposed a Class III designation in 1982, and in 1983 the FDA Advisory Panel unanimously agreed.  In 1988, the FDA Advisory Panel met again and an FDA official, Dr. Nirmal Mishra, listed the possible risks of breast implants that needed to be studied, including:

  • Capsular contracture (the painful tightening of the scar tissue around the implant)
  • Breakage
  • Micro-leakage (sweating or bleeding of silicone outside the shell)
  • Silicone leakage to the lymphatic system
  • Interference with the accuracy of mammography
  • Immune disorders
  • Cancer

Thirty years later, these are still the issues of greatest concern, and the incidence of these complications as implants age is still unknown.

By 1990, almost one million women had breast implants, even though there were no published clinical trials about their safety and the FDA had never approved them.  The FDA oversight committee in the House of Representatives, under the Chairmanship of Rep. Ted Weiss, held a hearing in December of 1990, pointing out that the only studies implant makers had submitted to the FDA were silicone injections in rats and rabbits, and that the agency had ignored that law requiring them to promulgate a rule requiring that human clinical trial data be submitted by the breast implant companies to the FDA if the wanted to keep selling their implants.8  Scientists testified about their research indicating substantial safety concerns, and patients testified for and against implants, depending on their personal experiences.

In response to Congressional pressure and negative media coverage, the FDA finally required the manufacturers of silicone gel breast implants to submit safety studies in 1991.  Studies of saline breast implants were not required at that time.  Unfortunately, the studies of silicone gel implants that were submitted to the FDA were poorly designed and conducted; for example, in the McGhan study, two out of three patients were followed for less than three months after their surgery, and there were only three breast cancer reconstruction patients.8

Early in 1992, internal memoranda dating from 1960-1987 from Dow Corning, the major breast implant manufacturer at that time, were publicly released.8  The documents were widely reported in the media, with quotable quotes such as a marketing representative telling physicians “with fingers crossed” that safety studies were underway. Several memoranda complained that new breast implants were “greasy,” indicating the micro-leakage of intact implants that the FDA had been concerned about years earlier.  Given the poor quality of the studies submitted to the FDA and the controversy about the internal documents, it is not surprising that silicone gel breast implants were not approved at that time.

Nevertheless, the FDA made sure that breast implants could still be sold in the U.S., by issuing a compassionate need exemption policy on October 23, 1992.8  This policy restricted silicone gel implants in the U.S. to women willing to participate in studies, including a large “Adjunct Study” for reconstruction patients and for women who wanted to replace broken implants (called “revision” patients).  Approximately 1,000 women, including first-time augmentation, reconstruction, and implant replacement patients participated in each company’s “Core Study.”  It is important to note that the companies defined reconstruction patients to include many women who were not mastectomy patients.  Women were also “reconstructed” to correct “deformities” such as droopy breasts (not uncommon after women have breastfed a child) and “severe” asymmetry; deformities were subjectively defined by the plastic surgeons.

Implant manufacturers could have collected and published extensive safety data from these studies.  Instead, major shortcomings were reported; for example, many patients reported that their physicians encouraged them to enroll in the Adjunct study as a way to qualify for silicone gel implants, explaining that they could drop out immediately after surgery. That anecdotal claim is supported by the large proportion of participants who dropped out between enrollment and the first follow-up, and even more after that: only 27% of Inamed’s reconstruction patients and 20% of their revision patients were followed for three years, as were 18% of Mentor’s revision patients and 19% of their reconstruction patients.9  The problem when so many patients drop out of studies is that it is impossible to know if the ones that dropped out have better or worse experiences than those in the study.  As a result of losing data from approximately three-quarters of the women before the study was completed, these Adjunct “studies” did not provide meaningful safety information.

After that same 2003 Advisory Panel meeting, the FDA considered the scientific data that had been provided and decided not to approve Inamed silicone gel breast implants in January 2004.10  At the same time, the FDA issued a new guidance specifying the type of research that manufacturers would need to submit to obtain approval of any breast implants in the future.  A major focus of the guidance document was the need to determine why breast implants break, how long they last, and the health consequences of broken and leaking implants.

In 2005, the FDA held another Advisory Panel meeting to consider new research on silicone breast implants that had been submitted by two companies, Inamed (now called Allergan) and Mentor (now a subsidiary of Johnson & Johnson).11 Their studies only followed women for three years, which was not responsive to the FDA guidance asking that they determine how long implants last or the health consequences of leaking or broken implants.

Meanwhile, controversies regarding implant safety continued.  In late 2005, the FDA Office of Criminal Investigation started an investigation of Mentor, interviewing former Mentor employee about the sale of defective implants by the company.  One employee admitted that executives ordered him to destroy documents related to a high rupture rate of Mentor implants and admitted that some implants were contaminated with fleas.12  

Despite the short-term studies and the investigation of Mentor, in November 2006 the FDA approved silicone gel breast implants by Mentor and Inamed (now Allergan) as “reasonably safe” for women who are 22 or older.  This was the first time that FDA had approved silicone gel implants, and because of serious concerns about safety, the FDA required each of the two implant makers continue their 2-3-year studies for a total of 10 years each, and also start new studies of at least 40,000 women with breast implants for 10 years, in order to prove long-term safety.13  The purpose of these larger, long-term trials was specifically to determine if there was a statistically significant risk of connective tissue or autoimmune diseases.

The required studies were an acknowledgement that previous studies had been too small or too short-term to determine if implants caused these systemic diseases, as well as to determine the long-term risk of documented problems such as implant breakage and breast pain.  With few exceptions, almost all the published data were studies funded by implant companies, plastic surgeons, or silicone manufacturer Dow Corning.  Although the required studies would still be funded by and conducted by the implant companies, the FDA had input into the scientific design of the studies to address the short-comings of previous research.

The required studies were conducted, but 5 years after silicone gel implants were approved, neither the companies nor the FDA had made any of the results publicly available.  Requests from the National Center for Health Research to make the data public received no response.  At that point, Congresswoman Rosa DeLauro (D-CT), who chaired the FDA Appropriations committee in the House of Representatives, requested that FDA hold a public meeting,14 and the FDA did so in August 2011.  The data were provided on the FDA web site in June 2011 and discussed at the August meeting.13  In addition to invited presentations by the implant companies and FDA officials, several hours were set aside for public comments.

The data in the FDA’s June 2011 report and as presented at the public meeting made it clear that most women enrolled in the required 10-year studies had dropped out within just the first few years.  More than three-quarters of Mentor’s 40,000 patients had dropped out, and at the meeting it was mentioned that Mentor had provided no stipend or other incentive for the patients to complete the very lengthy annual surveys describing their health issues.  In contrast, Allergan had paid women $20 each to complete very similar questionnaires.  Moreover, several women testified at the hearing that they were thrown out of the implant studies when they reported serious health problems from their breast implants or decided to have their implants removed.15  It was impossible to determine how often that happened, but it raised questions about the accuracy of the data provided by the companies, as well as the possible reasons why so many women “dropped out” of the studies.  Nevertheless, the FDA did not question the integrity of the data and maintained in their report that silicone implants were safe and effective.13

FDA states on its website that the 10-year studies of 40,000 women that FDA required of each of the two implant companies were never completed.16  FDA reports that their Advisory Panel that met in 2011 recommended that the 10-year studies be replaced by a systematic literature review as well as re-designed studies that “have more efficient methodologies to assess rare complications.”  On its website, FDA explains that “In response, FDA entered into collaboration with the American Society of Plastic Surgeons (ASPS), the Plastic Surgeons Foundation (PSF), breast implant manufacturers and patient advocate groups, to establish the National Breast Implant Registry (NBIR) and the PROFILE Registry (established to collect data on potential cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL)). Tufts University was tasked with conducting a systematic literature review to look at rare endpoints (listed below) and silicone gel-filled breast implants.  Despite the FDA’s description of the panel’s recommendation to replace post-market studies with a research review, the FDA’s own summary of the meeting is completely different, focusing on the need for clinical trials and registries to answer important safety questions.17

Our analysis of the Tufts review is on page 15 of this report.  It is important to note that although the FDA claimed they would include “patient advocacy groups,” none of the patient advocacy groups that were most involved in the FDA’s breast implant hearings were invited to participate in the registries or the Advisory Board of the Tufts Systematic literature review.  In addition to being funded by implant manufacturer through a grant to the Plastic Surgeons Foundation, the Advisory Board was comprised primarily by plastic surgeons and industry representatives and its only “patient advocate” was head of an organization that had received funding from implant manufacturers.

Breast Implant Design Innovations

One of the difficulties of studying breast implants is that the implants have changed over time.  The 50+-year history of silicone breast implants is a history of trying to reduce complications, especially common problems such as implant rupture or breast hardness and pain caused by capsular contracture.  Although breast implants were not studied in clinical trials for the first 30 years that they were used, companies introduced design modifications that were intended to make implants safer but were later be found to be ineffective at fixing problems and caused new ones.  For example, since the mid-1960s, implant modifications have included adding a Dacron patch to fix the implant in place; removing the Dacron patch; changing the thick gel to a thinner gel; changing the thinner gel to a thicker, more cohesive gel; making the silicone shell textured, covering the shell with polyurethane foam; removing the foam when it was found to break down to a carcinogen; making the shell smooth; changing the shape of the implants; and reducing “silicone bleed.”  Rather than being studied in clinical trials, women paid for surgery with these different types of implants. A Congressional report summarizing these changes referred to the patients as “guinea pigs.”8

When research was finally conducted and showed problems, companies could claim that the newly designed implants were safer.  For example, women were told that the new breast implants approved by the FDA in 2006 were improved but Inamed’s Senior Director of Regulatory and Clinical Affairs testified to the FDA in 2003 that the implants on the market at that time, which were included in the studies “is basically the same product it was 10 years ago…it is essentially the same product.9

In addition to changes they made to silicone gel breast implants, implant makers sold implants that replaced silicone gel with other products.  Implants made with a silicone elastomer envelope that is filled with saline (salt water), have been available for decades, but were not approved by the FDA until 2000.  The companies had conducted 3-year studies of local complications such as pain, infection, hardening, and the need for additional surgery.  They did not study other health problems.

In addition to saline, three other kinds of implants were made available in the 1990’s, primarily outside the United States: Trilucent implants (with soybean oil filler), and Novagold and PIP hydrogel implants, which were filled with a plastic gel.  Although never approved as safe in the U.S., these implants were vigorously promoted by plastic surgeons and the media as a “natural” and safer alternative to silicone or saline implants.  Clinical trials, however, were apparently never conducted on humans with these implants, and all were removed from the market in 2000 due to safety concerns.18,19,20,21  Their removal from the market serves as a reminder that the long-term risks of implants are not always obvious during the first few years of use.

In 2012, FDA approved silicone gel implants made by a third company, Silimed, without a public meeting to review the much more cohesive implants made by Silimed.22  This was the first “gummy bear” silicone gel implant, the nickname given because the gel has a  rubbery consistency like gummy bear candies.  The goal of using such cohesive gel is to prevent leakage if the implant breaks.  However, the metals and chemicals that are used to make it are different from other silicone and the long-term risks are unknown.23   This very different implant should have been publicly scrutinized at an FDA Advisory Panel meeting, but it was not.

FDA has approved specific models of silicone or saline breast implants made by Inamed, Mentor, Silimed (also called Sientra), and Ideal Implant.  Implants made by several other companies, such as those made by the French company PIP, have been sold in other countries but have not been available in the U.S. for over a decade.  PIP silicone implants were taken off the market in Europe in 2011 because they tended to rupture sooner than other implants and because testing revealed that the silicone was not intended for use in the human body but rather was intended for use in mattresses.3,4  Public outrage and concern was so strong in several countries, such as France, the United Kingdom, Bolivia, and Venezuela, that their governments agreed to pay for implant removal surgery for all PIP implant patients, including cosmetic patients.24

Frequency of Local Complications

Everyone agrees that breast implant surgery has risks.  The risks associated with any type of surgery include infection, hematoma (blood or tissue fluid collecting around an implant), and the risks associated with anesthesia.

Everyone also agrees that breast implants can cause “local complications” in the breast area.  The only controversy is how often these problems happen, due to the absence of long-term studies.  These are the most common local complications.

Breast Pain and Capsular Contracture: All implants are “foreign bodies.” A woman’s body reacts to the introduction of this foreign object by forming a capsule of scar tissue around the implants. When this capsule becomes tight or hard—a common problem—it is called capsular contracture. Capsular contracture can cause the breasts to become very hard or misshapen and can cause mild discomfort or severe, chronic pain. Research submitted in support of Inamed’s 2003 application to the FDA, for example, reported severe capsular contracture occurring in 16% of reconstruction patients and 8% of augmentation patients within 3 years.9

Comparing Inamed data on saline breast implants and silicone gel breast implants shows many of the same types of complications; however, complication rates from silicone gel implants tend to be higher.  For example, 46% of silicone gel reconstruction patients and 21% of saline reconstruction patients underwent at least one additional operation within three years, 25% of silicone patients and 8% of saline patients had implants removed, and 6% of silicone patients and 16% of saline patients had breast pain.  3-year data of Mentor and Inamed analyzed by the FDA in 2000.  Complications were lower but still substantial for augmentation patients.7,9

A study of Danish women who had breast implants for an average of 19 years found that women with implants were almost three times as likely to report breast pain compared to breast reduction patients.25  In addition, two-thirds of the women with implants reported moderate or severe breast hardness.

There are other well-documented complications that affect the breasts that can result from breast implants. For example, some women lose sensitivity in their nipples, and others become overly sensitive.  These problems can interfere with sexual intimacy.  The cosmetic outcome is also sometimes disappointing, with breasts looking or feeling unnatural or asymmetrical.

Rupture: All breast implants will eventually break. When silicone gel breast implants break, there are often no symptoms, so accurate estimates of rupture rates depend on magnetic resonance imaging (MRIs). While most breakage occurs as the implants age, Inamed’s study of their silicone gel implants found that 1-6% break within three years. 26  In a study conducted by researchers at the FDA, most women had at least one broken implant within 10 years, and the likelihood of rupture increased over time.27  The women in the FDA study had not had their implants removed, did not know that their implants were broken, and were not seeking help because of implant concerns.  Despite the fact that these women were “satisfied customers” rather than women seeking medical care, MRIs found that silicone had migrated outside of the breast capsule for 21% of the women in the study.  Most of the women were unaware that this had happened.  A Danish study reported that most silicone gel implants lasted for ten years; however, by the time the women in that study had implants for 15 years or more, a substantial percentage of the implants broke every year.28

Leakage: Numerous studies have shown silicone leaked into the scar capsules surrounding breast implants, even for implants that were not ruptured. More worrisome, researchers at Case Western Reserve and the Armed Forces Institute of Pathology reported finding silicone in the lymph nodes of women with breast implants, which can then migrate to other organs.29,30  Case studies have confirmed that silicone can migrate to the lymph nodes.31,32  Silicone in the lymph nodes can only be removed by removing the lymph nodes. Silicone in organs such as the lungs, liver, and brain cannot be removed.  The health risks associated with migrated silicone gel are unknown.  However, case reports have indicated fatalities and serious health risks when liquid silicone injected in the breasts migrated to the lungs or other organs.  Although silicone implants are filled with gel rather than the liquid form of silicone, the implants sometimes leak a silicone liquid or thin gel.

Mammography: Breast implants interfere with the detection of breast cancer because implants can obscure the mammography image of a tumor.  Implants therefore have the potential to delay the diagnosis of breast cancer.  Although special techniques are designed to minimize the interference of the implants, research indicates that 55% of breast tumors may still be obscured, compared to 33% obscured in women without implants in the same study.33  Mammograms tend to be less accurate if the woman has capsular contracture. In addition, women with implants may be reluctant to undergo mammograms because of fear of rupture, and a study by FDA scientists indicates that silicone or saline implants sometimes rupture when women undergo mammograms.34  The alternative, undergoing a regular breast coil MRI to check for cancer, is prohibitively expensive for many women at $2,000 each time.

Although there is no research evidence that implants cause breast cancer, a delay in diagnosis could have serious health implications and decrease women’s options for breast-conserving surgery. Such delays have been reported by patients but not in studies. Although breast cancer rates tend to be lower in women with breast implants, that is thought to be related to the lower BMI and smaller breasts typical of women who undergo augmentation.

Breastfeeding: Women who have had any kind of breast surgery, including breast implant surgery, are up to three times more likely to have an inadequate milk supply for breastfeeding.30 Concerns about the chemicals from the implants passing to infants through breastfeeding have also been raised, with conflicting evidence and insufficient research information available to make a determination on this risk.

Cancers, Lymphoma, and Lung Disease

In January 2011, the FDA announced that women with breast implants seem to be more likely to develop ALCL (anaplastic large cell lymphoma), a rare cancer of the immune system.  This apparent link was confirmed, and the WHO and NCCAN both recognized “Breast Implant Associated ALCL (BIA-ALCL) in 2016.  The risk of developing ALCL is very low, but much higher in women with implants than it is in the general population.  For women with implants, ALCL has been found in fluid surrounding the implant and in the scar capsule; ALCL is not usual in the breast area for women who do not have breast implants. There is evidence that ALCL is more likely in implants with textured surfaces than with smooth surfaces.35  The FDA is now requesting that physicians report cases of ALCL in women with breast implants to determine how great the risk is compared to women without implants and to talk with patients about the benefits and risks of textured-surface vs. smooth-surface implants.36

Although not announced to the public until 2011, there were published case studies of BIA-ALCL as early as 2008, and plastic surgeons were discussing their concerns about it with each other but not with patients.  Why did it take more than 50 years to confirm this link to cancer?  Implant manufacturers and plastic surgeons continued to state that breast implants did not cause cancer even after they suspected that implants could cause ALCL.

There is clear evidence that ALCL can develop within a few years of a woman getting breast implants; however, most cancers take many years to develop after an exposure.  A study by scientists from the NCI found that women with breast implants were more likely to die from brain cancer, lung cancer, and other respiratory diseases, compared with other plastic surgery patients.37  The NCI study compared augmentation patients to other plastic surgery patients, who were very similar in socio-economic status, health status, and health habits (including smoking).  All the women in the study who had implants had them for at least 12 years.  Although this is not a long enough follow-up period for a conclusive cancer study, it is considerably longer than most other implant studies, and it has an appropriate comparison group of other plastic surgery patients.

A second NCI study found a 21% overall increased risk of cancer for women with implants, compared with women of the same age in the general population.38  The increase was primarily due to an increase in brain cancer, respiratory tract cancers, cervical cancer, and vulva cancer. Swedish and Danish studies also found a significantly increased risk of lung cancer among augmentation patients, but those studies did not control for smoking.39,40

The Main Controversy: Autoimmune, Connective Tissue Disease, and Breast Implant Illness

The greatest controversy regarding the risks of breast implants concerns the question of whether they increase the risk of autoimmune disease and connective tissue disease. This issue has gained more recent attention now that it is clear that implants can cause ALCL, a cancer of the immune system.  If implants can cause cancer of the immune system, does that mean implants can cause other immune disorders?

As noted earlier in this report, more than 50,000 women have joined two Facebook groups of women who say their breast implants cause symptoms that they refer to as “breast implant illness.” Doctors classify many of the symptoms they are reporting as connective tissue or autoimmune symptoms, but in many cases the women are not diagnosed with a specific autoimmune or connective tissue disorder (CTD).

Nevertheless, plastic surgeons and implant manufacturers have consistently claimed that there is “no evidence” that breast implants cause autoimmune or connective tissue problems.  Our scientific scrutiny of the research has determined that these claims of “no evidence” are inaccurate.  The remainder of this report will examine the evidence that is quoted by implant manufacturers and plastic surgeons, as well as the studies and results that they have often ignored.

We will start with a review of a few of the studies that indicate that breast implants are associated with autoimmune or connective tissue symptoms, whether or not they are associated with classic disease diagnoses such as Rheumatoid Arthritis (RA), scleroderma, Sjögren’s Syndrome, and other specific diseases.  We will not perform a traditional systematic review of the literature or a meta-analysis, because such efforts too often focus on important standards such as controlled clinical trials while ignoring the even more important flaws that are unique to the issues under investigation.  For example, a study that relies on hospitalization records as a way to diagnose autoimmune disease is not appropriately designed to analyze the health effects of breast implants, especially not for women who had those breast implants for a short period of time.  Instead our report will scrutinize what the previous systematic reviews and meta-analyses have failed to consider, by examining the extent to which the individual studies included in previous analyses are or are not adequate to determine the systemic, long-term symptoms and conditions caused by breast implants.

A large retrospective study published by Watad et al in 2018 reported a statistically significant 22% increase in several autoimmune or rheumatic disorders, although the prevalence of Sjögren’s syndrome, MS, and sarcoidosis each increased by at least 60%.  That analysis was based on almost 11,500 Israeli women with breast implants confirmed by medical records and almost 46,000 matched women who had no breast implants.  The analyses of diseases were based on diagnoses made after the women got breast implants that were included in medical records during a period up to 20 years.41

Another large study published concluded that “silicone implants are associated with an increased risk of certain rare harms” and that further study is needed “to inform patient and surgeon decision-making.”42  The study is described as an analysis of almost 100,000 women with Mentor or Allergan silicone gel breast implants, but 80% of approximately 50,000 Mentor patients dropped out before their self-reported questionnaire data were collected 7 years after getting implants.  Allergan’s data were based on physicians’ diagnoses of 60% of their patients two years after their implant surgery.

Despite these shortcoming, it is important to note that the researchers reported that the risks of certain autoimmune diseases increased significantly for women with implants; for example, there was an 800% increase in Sjogren syndrome, 700% increase in scleroderma, and 600% increase in arthritis among women with Mentor breast implants compared to the general population of women of the same age and demographics.  Allergan patients had double the rates of many of the same diseases, but there were fewer diagnoses since they were based on  physicians’ diagnoses after only 2 years.

These two large studies documenting a link between breast implants and autoimmune or connective tissue diseases confirms what older, much smaller studies also reported.   For example, a study conducted by FDA scientists during the 1990’s found a statistically significant link between breast implants and fibromyalgia, as well as several connective tissue diseases.43  The study included women who had silicone breast implants for at least six years and found that women with leaking silicone implants were significantly more likely to report a diagnosis of painful and debilitating diseases such as fibromyalgia, dermatomyositis, polymyositis, Hashimoto’s thyroiditis, mixed connective tissue disease, pulmonary fibrosis, eosinophilic fasciitis, and polymyalgia.  The risk of fibromyalgia remained even after controlling for patient’s age, implant age, and implant manufacturer.  Extracapsular leakage was evaluated in the study using an MRI.

Around that same time, scientists at the National Cancer Institute (NCI) found a statistically significant increase in reported connective tissue diseases among breast augmentation patients; the women in their study had implants for at least seven years. They also found that many of the women made errors in their self-reported diagnoses.44 For example, many women who reported having rheumatoid arthritis actually had osteoarthritis according to their medical records.  The findings suggest that there are increased symptoms among women with breast implants, but it is not clear if there is an increase in specific diagnoses.  Although the researchers concluded that the associations between breast implants and arthritis, scleroderma, Sjögren’s syndrome, and other connective tissue diseases need further study, they did not consider an alternative hypothesis: perhaps implants cause symptoms that do not precisely fit the criteria of these diseases.

As noted in the study conducted by the National Center for Health Research (pg. 2), the reasons why women decide to have their implants surgically removed and not replaced is often due to symptoms of autoimmune and CTDs, rather than diagnoses. The women and their doctors often report a constellation of symptoms that do not fit the exact criteria of known diseases.  A major weakness of most breast implant studies funded by implant manufacturers and plastic surgeons is that they only evaluated diagnosed diseases rather than symptoms. This shortcoming is exacerbated when the studies include women who have had breast implants for relatively short periods of time, since the women’s symptoms are likely to be apparent for years before a diagnosis is made.

Fortunately, as part of the applications submitted to the FDA by Mentor and Allergan for approval for their silicone gel implants in 2005, they submitted data comparing the signs and symptoms of connective tissue diseases before and two years after patients got breast implants.  The companies reported that these signs and symptoms increased significantly over those two years, although they blamed the changes on age.

Nevertheless, scientists who wrote the official FDA Summary for Inamed/Allergan patients stated that there was evidence in the research literature that implants were associated with an increase in some connective tissues diseases and that in Inamed’s own data, “the increases in the following CTD categories occurred despite age”: general issues, muscle weakness, joint pain, and skin symptoms.11

For Mentor implants, the FDA reported statistically significant increases in fatigue, exhaustion, joint swelling, frequent muscle cramps, joint pain, and fibromyalgia among augmentation patients, which the FDA concluded were not due to age.

In the one other study comparing symptoms before and after women had their breast implants removed, Aziz et al examined 95 women who had silicone gel-filled breast implants and diagnosed rheumatologic symptoms.  These researchers found that the symptoms improved in 42 (97%) of the 43 women who had their breast implants removed and not replaced.45  In contrast, rheumatologic symptoms worsened in 50 (96%) of the 52 women who did not have their implants removed.

A study by Brieting et al stands out because it reported statistically significant increases in connective-tissue and autoimmune problems for women with breast implants and yet concluded that exposure to breast implants “does not appear to be associated with” autoimmune “symptoms or diseases.”25   This study of Danish women who had breast implants for an average of 19 years found that they were significantly more likely to report fatigue, Raynaud-like symptoms (white fingers and toes when exposed to cold), memory loss, and other cognitive symptoms than women of the same age in the general population. Ten percent of the women with implants had already had their implants removed and not replaced, which might have reduced these symptoms for those women in the study.  Despite stating that women with implants were between two and three times more likely to report those symptoms, the researchers concluded that there was no apparent link between breast implants and these “symptoms or diseases.”  In addition, the women with breast implants were at least six times as likely to be taking antidepressants as breast reduction patients and at least four times as likely as women in the general population.  The increase in antidepressants and sedatives were even higher for women who had their implants replaced at least once.  As we will note later, that inaccurate conclusion is often quoted, whereas the results are not.  The authors of this study include the director of the International Epidemiology Institute, which was funded by silicone manufacturer Dow Corning.

Depression is not usually included in the studies of breast implants and autoimmune diseases, most of which focus on connective tissue diseases (many of which are also autoimmune diseases.  For that reason, we did not focus on data on depression in this report.  However, studies conducted in numerous countries consistently indicate an increase in suicides among women with breast implants,46 and depression should be studied in future research.

In addition to the examples above, it is important to note that former FDA researchers have reported that silicone stimulates an immune response, and their cellular analyses indicate that these responses are associated with atypical forms of connective tissue disease.47

Does Research Prove that Breast Implants Don’t Cause These Diseases?

How is it that despite these and other studies indicating significant increases in autoimmune or CTD diseases or symptoms among women with implants, the research reviews conducted by the FDA and others instead claim there is not such evidence?  There are numerous reasons, but one is that the research reviews tend to rely on early studies of women who had implants for a relatively short time, ranging from a few months to a few years.

These flawed studies comprised most of the studies evaluated in two influential reports:  1) A report by the Institute of Medicine (IOM) and 2) A meta-analysis published in the New England Journal of Medicine that was based on an analysis prepared for Judge Pointer’s National Science Panel.48,49  These reports are based on overlapping 17-20 studies that were published prior to 1999, most of which were funded by Dow Corning at a time when the company was being sued by patients harmed by breast implants.  Since many connective tissue and autoimmune diseases are relatively rare and most take many years to develop and be diagnosed, these small, short-term studies were not appropriately designed to answer questions about long-term breast implant safety.  Most notably, the largest study

Their major flaws are as follows:

  • The case-control studies relied on women accurately telling a stranger whether they had breast implants, and most included very few women who admitted to having breast implants. The accuracy of their responses was not verified.
  • The studies include substantial numbers of women who had implants for just a few months or years.  Very few of the studies included women who had implants for an average of 8 years or more, and some included few if any women who had implants for that long. Compared to the women in the current study of the National Center for Health Research (page 1), these women were exposed to implants for a much shorter period of time.  As a result, these studies could not conclusively evaluate the long-term increased risk of disease.
  • Almost all the studies relied on disease diagnoses rather than symptoms.  The diagnoses were based on hospital records or self-report, not medical exams. Several studies had an even greater flaw:  Disease diagnosis was based on hospital records rather than medical diagnoses. Most women with autoimmune symptoms or diseases are not treated in hospitals.

For example, among the studies reviewed by the IOM, only one study, by Schusterman et al, included a diagnosis based on a previously recorded medical exam, and all the women in that study had implants for less than two years — too short a time to meaningfully evaluate disease risk.  In addition, several European studies (Friis et al; Nyren et al) that found an increased risk of CTDs among women with breast implants inaccurately concluded that they had not found such an increase.50,51  Their misleading conclusions were based on comparing CTD diagnosis among breast augmentation patients to breast reduction patients, which did not differ significantly.  However, the articles clearly stated that both breast surgery groups had a higher proportion of women with these diseases than expected based on the general population of women of that age.  Therefore, the interpretation of “no increased risk” was inaccurate, since both types of breast surgery patients were apparently more likely to develop CTDs.  Although the increase might have been due to the surgery rather than the breast implants per se, what is important to patients is that breast implant surgery significantly increases their chances of developing those diseases.

In summary, the claim that there is “no evidence” of a link between breast implants and CTDs or autoimmune health issues diseases is not accurate. Research results regarding these symptoms and diagnoses are inconsistent for a variety of reasons that we will scrutinize below.  Self-reports tend to show significant increases in health risks, whereas studies that rely on diagnoses in medical records and hospitalization are less likely to show significant increased risks.  In industry-funded studies, even when studies indicate an increase in symptoms or diseases among women with implants, the authors sometimes conclude that there is no evidence of increased health problems.

To fully explore this controversy, we will examine the history of research on breast implants:  Who conducted it, who paid for it, who publicized the results, and how that information influenced physicians, patients, and the public.

As noted earlier in this report, breast implants were sold starting in the 1960’s, but there were no published scientific studies until after Congressional hearings received widespread media coverage in 1990 and 1991.  The studies that were conducted in the 1990’s were almost entirely funded by Dow Corning, conducted by a core group of researchers at the International Epidemiology Institute, which received substantial funding from Dow Corning and other industry groups that needed research evidence to defend their products.  The Dow-funded studies were used by Dow to defend the company from liability from their silicone implants and the silicone they sell to other companies.

We will now review the studies used as the basis of 3 key reports:  The IOM report and New England Journal of Medicine (NEJM) meta-analysis mentioned above, and a report by TuftsCenter for Clinical Evidence Synthesis that the FDA has cited as evidence that post-market clinical trials are not needed to study the impact of implants on autoimmune or connective tissue diseases. 

The studies cited in the IOM and NEJM reports overlap almost completely: 15 of the 17 studies cited by IOM comprise 75% of the 20 cited in the meta-analysis. The 390-page Tufts review funded by implant manufacturers that was published 16 years later includes 114 research citations on a wide range of diseases, not just CTDs and autoimmune diseases.52  However, they do not go into any depth on those 114 studies.  For that reason, our analysis will focus on the article the Tufts authors published in medical journal based on the same report but focused on the studies that the authors consider most scientifically sound.  That published article focused on 32 studies of a wide range of diseases; 9 of the 22 studies of CTD and autoimmune diseases that were the focus of the Tufts article were included in the IOM and/or NEJM meta-analysis.53 All 3 reports concluded that the studies do not indicate an association between silicone breast implants and connective-tissue disease, although the Tufts analysis is focused primarily on silicone gel implants rather than all breast implants.

Since the overlap in studies is so substantial for the IOM and NEJM reviews, we will focus on those studies first.  A careful review of the 22 studies that were included in the IOM report and/or the meta-analysis reveals that most of those studies have a number of major flaws. The accuracy of any report, meta-analysis, or review depends on the quality of the studies included in that analysis but also on how contradictory findings are explained.   However, the NEJM authors also made an unusual statistical decision: When the meta-analysis indicated that the Hennekens study was largely responsible for the significant increase in several diseases among women with breast implants, the authors excluded the Hennekens study from the meta-analysis.  They justified the exclusion on the basis of the fact that the diagnoses were self-reported, even though the patients making the reports were health professionals.  The NEJM authors then focused on the lack of statistically significant findings of the meta-analysis when the Hennekens study was excluded, and concluded that implants did not cause disease.

Because the NEJM meta-analysis was prepared for Judge Pointer as part of a major law suit, the decision to exclude the Hennekens study has enormous implications for patients.  It made it impossible for implanted women who developed autoimmune diseases or CTDs to be compensated or to have their health insurance policies pay for explant surgery.  And yet, when we scrutinized these 22 studies, we found numerous studies with much greater flaws than the Hennekens study.

Here are the shortcomings of the 22 studies:

  • Twelve studies compared women with specified CTD to women without, to determine if more women with CTD had breast implants.  In most of these studies, between 1-10 women had breast implants, making it impossible to determine if implants cause disease.
  • Four studies cited were not published in peer-reviewed journals. Instead they were papers presented at scientific meetings or unpublished doctoral dissertations, with limited information on methodology available to evaluate the validity of the study designs.
  • Of the 22 studies, only three evaluated the symptoms frequently reported by breast implant patients, such as joint or muscle pain, chronic fatigue, mental confusion, or general body pain.
  • Two of the 19 studies that excluded symptoms evaluated diagnoses based on hospitalization, not outpatient treatment.  This is an enormous flaw, since few women who were healthy enough to undergo cosmetic surgery are likely to be hospitalized for CTD or autoimmune diseases unless the disease has progressed for many years.
  • Only one of the studies required patients to undergo a comprehensive medical exam as part of the research, as well as including patient-reported health issues.
  • At least six of the studies included women who had implants for a year or less.  Unfortunately, most of the studies did not include information about the minimum number of years the women had implants, the number of years of exposure would obviously influence the development of symptoms or diseases.  Symptoms or diseases might also be more likely after a silicone gel implant ruptures and leaks, which usually occurs after 7-10 years. Therefore, a well-designed study would include women who had implants for at least 7-10 years.  Only one of the 10 cohort studies included women who had implants for an average of 10 years or more.
  • Most of the studies did not evaluate mastectomy patients separately to determine if the results were relevant to them.
  • Almost all of the samples are too small to study these relatively rare diseases, and thus, have limited power to detect increases in the rates of disease, even increases as large as 50-200 percent.
  • In at least one of the studies, women were included in study even if they had their breast implants removed shortly after they got them. The majority of the studies failed to mention whether women who were identified by medical records as having implants still had them throughout the years that their data were analyzed. Those omissions potentially bias the findings because women who had implants removed do not have the same amount of exposure as women who have implants continuously.
  • The funding of most of these studies involved financial conflicts of interest. At least 10 of the 22 studies were funded by Dow Corning or the authors had served as paid expert witnesses defending Dow or another implant company. At least one of the studies was funded by the Plastic Surgery Foundation, which receives support from implant manufacturers and at least 3 other studies were conducted by plastic surgeons who were studying patients treated at their practice or Department.

The following summaries include basic information, including methodological shortcomings, about the studies included in the three key reports that concluded that breast implants do not cause autoimmune or connective tissue disease (CTD).  The first 20 summaries are for the studies included in the often-quoted meta-analysis published in the New England Journal of Medicine.  Fifteen of these studies were also included in the Institute of Medicine report and 9 of these studies (Burns et al, 1996,54 Edworthy et al, 1998,55 Friis et al, 1997,50 Gabriel et al, 1994,56 Giltay et al, 1994,57 Nyrén et al, 1998,51 Park et al, 1998,58 Schusterman et al, 1993,59 and Wells et al, 199460) were also a focus of the Tufts analysis that has been cited by the FDA as proof that breast implants do not cause autoimmune problems or CTD.

Unless otherwise noted, the following 20 studies that were included in the meta-analysis were also included in the IOM report and Tufts report.

Cohort Studies in the Meta-Analysis

Cohort studies compare women with breast implants to a group of women who are similar in terms of age, race, and health who did not have breast implants.

A Clinical Study of the Relationship between Silicone Breast Implants and Connective Tissue Disease (Edworthy et al. 1998)55

This study included 1576 Canadian breast augmentation patients and 727 women with classic connective-tissue disease were evaluated based on medical records; patients were not directly examined.  The average length of times with implants was 13.5 years; no minimum number of years was stated.

Women with breast implants were 44% more likely to have a diagnosis of rheumatoid arthritis (relative risk: 1.44), but that difference was not statistically significant. When interviewed about their health, women with implants were significantly more likely to have difficulty solving thought problems, have numbness in their extremities, muscle pain, headache, and hand pain. The analysis was measured by relative risk however, those symptoms were not included in the meta-analysis.

Connective Tissue Disease and Other Rheumatic Conditions Following Breast Implants in Denmark (Friis et al. 1997)50

This study included 2,570 Danish augmentation or reconstruction patients compared to 11,023 women who underwent breast reduction or mastectomy without implants.  Only women who were hospitalized with classic connective-tissue disease or with “other and ill-defined rheumatic conditions” were diagnosed.  The average length of times with implants was 7 years for reconstruction and 8 years for augmentation; women who had implants for less than one year were included.

According to the authors, the study had only limited power to detect an increased risk of any specific connective-tissue disease. The authors found an increase in rheumatic complaint in all of the groups and therefore concluded that breast surgery increases the risk of connective-tissue disease, and that the implants themselves do not cause connective-tissue disease.

This study was funded by Dow Corning.

Risks of Connective-Tissue Diseases and Other Disorders after Breast Implantation (Gabriel et al. 1994)56

This study included 749 Minnesota augmentation or reconstruction patients who received some treatment at the Mayo Clinic, compared to 1,498 women served by the Mayo Clinic around the same time but who did not have breast implants, some of whom had undergone mastectomies.  Diagnoses of classic connective-tissue diseases, Hashimoto’s thyroiditis, cirrhosis, or sarcoidosis were based on medical records. The average length of times with implants was 8 years; women who had implants for less than one year were included.

Women with breast implants had a 35% higher rate of arthritis, which was not statistically significant (relative risk: 1.35). Morning stiffness was 81% higher for implant patients, which was significantly higher than for women without implants (relative risk: 1.81). The authors estimated that they would need to have studied 62,000 women with implants for an average of 10 years to detect a substantial increase in rare diseases such as scleroderma.

This study was funded by the Plastic Surgery Educational Foundation.

Silicone Breast Prostheses and Rheumatic Symptoms: A Retrospective Follow Up Study (Giltay et al. 1994)57

This study included 235 implant patients, only 56 of whom were reconstruction patients, compared to 210 women who had undergone other cosmetic surgery not involving silicone.  Rheumatic complaints, use of anti-rheumatic drugs, and medical consultations regarding rheumatic symptoms were asked in a patient questionnaire; for those reporting rheumatic symptoms, a rheumatologist made an assessment of the likelihood of a rheumatic disease.  The average length of times with implants was 6.5 years; the minimum was 2 years.

Women with silicone breast implants reported significantly more rheumatic complaints than controls, but there was no evidence of increased prevalence of common rheumatic diseases, such as fibromyalgia, rheumatoid arthritis, or Sjögren’s disease. Augmentation and reconstruction patients were not evaluated separately.

This study was conducted by plastic surgeons and apparently included their own patients.

Self-Reported Breast Implants and Connective-Tissue Diseases in Female Health Professionals (Hennekens et al. 1996)61

This study included 10.830 augmentation or reconstruction patients compared to more than 380,000 other women; all were health professionals.  Classic connective-tissue disease or mixed connective tissue disease were self-reported.  The average length of times with implants was not provided but ranged from 1 year to more than 10.

Implant patients had a 25% higher rate of connective-tissue disease, whether they were reconstruction or augmentation patients (relative risk: 1.25). This was statistically significant, and the researchers concluded that there is a small increased risk of connective-tissue disease among women with implants. Although it is a cohort study, this study was analyzed with case-control and cross-sectional studies in the meta-analysis because information about the disease and the patient’s exposure to silicone breast implants was gathered at the same time.

This is one of the very few Dow-funded studies that reported an increase in connective tissue diseases.

The significant findings in this large study resulted in the NEJM meta-analysis concluding that breast implants were associated with several CTDs.  The NEJM authors then excluded the Hennekens et al findings from the meta-analysis and concluded that breast implants do not increase the risk of CTD.

This study was not analyzed in the Tufts report.

Risk of Connective Tissue Disease and Related Disorders Among Women with Breast Implants: A Nation-Wide Retrospective Cohort Study in Sweden (Nyren et al. 1998)51

This study included 7,442 Swedish augmentation or reconstruction patients compared to 3,352 women who underwent breast reduction.  Only women who were hospitalized with classic connective-tissue disease or “related disorders” were diagnosed.  The average length of times with implants was 6 for reconstruction and 10 for augmentation; women who had implants for at least one month were included.

According to the authors, the study had only limited power to detect an increased risk of any rare connective-tissue disease, such as scleroderma.  The authors found a 10% increase in connective-tissue disease for women with breast implants and 30% increase for breast reduction patients, in both cases compared to the general population.  They concluded that breast surgery rather than implants causes the increase and concluded “no evidence of an association between breast implants and connective tissue disease.”

This study was funded by Dow Corning.

Silicone Gel-Filled Breast Implants and Connective Tissue Diseases (Park et al. 1998)58

This study included 317 Scottish implant patients, 207 of whom were reconstruction patients, compared to 419 women who had undergone other outpatient cosmetic surgery or were from the maternity ward.  Women were interviewed and received a medical examination to determine signs and symptoms of connective tissue disease. The average length of times with implants was 6 years for reconstruction patients and 5 years for augmentation patients; no minimum was specified.

Because the sample size was so small, the authors acknowledge that a health risk would have to exceed 320% for reconstruction patients and 1600% for augmentation patients in order to be statistically significant. The fact that many of the women had implants for a relatively short period of time also undermines the credibility of the results, as does the fact that this study is conducted by plastic surgeons apparently studying their own patients.

Silicone Breast Implants and the Risk of Connective-Tissue Diseases and Symptoms (Sanchez-Guerrero et al. 1995)62

This study included 1,183 augmentation and reconstruction patients, compared to 86,318 other women; all were participants in the U.S. Nurses’ Health study who completed questionnaires asking whether they had breast implants and whether they had any classic connective-tissue diseases. Women with milder or atypical cases were excluded. The average length of times with implants was 10 years (see below for problems with that statistic), and the minimum amount of time with implants was one month.

According to the authors, the study does not exclude small health risks of implants that would be of public health importance. The study was designed to minimize “reporting bias” of health problems by implant patients by excluding any health problems diagnosed after May 1990, which was six months before the major media coverage of implant problems. The researchers did not minimize bias in the opposite direction; for example, they included women who only had implants for one month as well as women who reported having breast implants since 1952 to 1961, although breast implants had not yet been invented.  For a random sample of 100 women, they verified whether the women had breast implants by looking at her medical records.

This study was not analyzed in the Tufts article.

Incidence of Autoimmune Disease in Patients after Breast Reconstruction with Silicone Gel Implants vs. Autogenous Tissue: A Preliminary Report (Schusterman et al. 1993)59

This study included 250 reconstruction patients with implants compared to 353 women who underwent breast reconstruction with autogenous tissue.  Patients were considered to have rheumatic disease if they had been seen by a physician who made the diagnosis on clinical grounds with corroborating laboratory evidence and had prescribed therapy. Only one woman with CTD was diagnosed in each group, but the number of patients was too small, and the length of follow-up was too short to be meaningful. The authors state that the report must be considered preliminary because the onset of autoimmune disorders could occur two to 21 years after implantation. Also, important to note that Friis et al and Nyren et al each concluded that any breast surgery patient would be at increased risk for an autoimmune disease.

This study was conducted by plastic surgeons apparently studying their own patients.

The Health Status of Women Following Cosmetic Surgery (Wells et al. 1994)60

This study included 222 Florida augmentation and reconstruction patients, compared to 80 women who underwent other cosmetic surgery. Women completed questionnaires that asked about 23 symptoms as well as the diagnosis of classic connective tissue diseases; unfortunately, more than half the women contacted did not participate. The women reported having implants for an average of 4 years, with no minimum reported.

The women with implants averaged 10 years younger than the other cosmetic surgery patients. Tender and swollen glands under the arm were seven times as likely in implanted women. Symptoms that were more frequent in implanted women but did not achieve statistical significance were: easily tired, muscle pain, swollen and tender glands in the neck, change in hand color with cold, weight gain, swollen and painful joints, and general stiffness. Arthritis was present in 5% of implanted women and 3% of controls. One implanted woman reported Raynaud’s disease; none of the women reported having scleroderma or lupus. The authors acknowledged that the small sample size could explain why the differences did not achieve statistical significance.

Case-Control or Cross-Sectional Studies in the Meta-Analysis

These studies compare women suffering from a particular disease (cases) to those who are healthy (controls) and determine whether breast implants are more common in the ill women.

Burns, Lacey, and Laing were co-authors that each were listed as first author of a study that was not peer reviewed.

The Epidemiology of Scleroderma Among Women: Assessment of Risk from Exposure to Silicone and Silica (Burns et al. 1996)54

This study compared 274 Michigan women with scleroderma to 1,184 identified by random digit dialing who were matched by age, race, and geography.  Medical information for the scleroderma patients were based on medical records, and for controls based on telephone interviews (accuracy of breast implant reporting was found to be 94%).

This small study revealed a nonsignificant 30% increased risk of scleroderma for women with silicone gel breast implants and the same risk for women with silicone chin implants.  The increased risk was slightly higher but still nonsignificant for other silicone implants, such as shunts and artificial joints.  In contrast, there was a statistically significant increase in scleroderma for women exposed to silicone through their jobs, suggesting that silicone exposure may be associated with scleroderma.

This study was funded by Dow Corning.

This study was not included in the Tufts published article.

Silicone Breast Implants and Risk for Rheumatoid Arthritis. (Dugowson et al. 1992)63

This study compared 300 women with rheumatoid arthritis to 1,456 other women matched on age.  All women completed a questionnaire asking if they had breast implants. They reported no link between RA and implants, but the sample is very small, and information is lacking about the research methods or analyses.  The results were reported at a scientific meeting in the form of an abstract that was not peer reviewed.

This study was not analyzed in the IOM study or the Tufts report.

Scleroderma and Augmentation Mammoplasty — A Casual Relationship? (Englert et al. 1996)64

This study compared 287 Australian women with scleroderma to 371 women who had visited randomly selected general practitioners.  Women were interviewed by telephone.  This small study revealed no increased likelihood that women with scleroderma reported having silicone breast implants, although the authors acknowledged that the study lacked the power to detect an increased risk if it were lower than 150-200%. The implant data were provided by the women and most were verified by plastic surgeons.

This study was funded by Dow Corning.

This study was not analyzed in the Tufts report.

Breast Implants, Rheumatoid Arthritis, and Connective Tissue Diseases in a Clinical Practice (Goldman et al. 1995)65

Instead of comparing sick women to healthy women, all of the women in this study were patients in a rheumatology practice. They compared 721 Atlanta women with connective tissue disease (CTD) to 3,508 Atlanta women with other rheumatology complaints, and medical records determined that 1.7% of the CTD women had implants compared to 3.9% of the other rheumatology patients.  However, the women who had breast implants were significantly younger than those who did not have implants. The authors acknowledged that since the study took place in the practice of a single clinician, there is the potential for referral or selection bias. Also, many patients were seen for only a single assessment, and the researchers acknowledged that losing women to follow up could have resulted in a selection bias.

This study was funded by Dow Corning.

This study was not analyzed in the Tufts report.

Lack of Association Between Augmentation Mammoplasty and Systemic Sclerosis (Scleroderma) (Hochberg et al. 1996)66

This study compared 837 Pittsburgh women with scleroderma to 2,507 women who were identified by random dialing and matched for age and race.  Women with scleroderma completed a self-administered questionnaire and the other women were interviewed by telephone.  This study revealed no increased likelihood that women with scleroderma reported having silicone breast implants, although the authors acknowledged that the study lacked the power to detect an increased risk. The implant data were unverified.

At least one of the authors of this study was paid as an expert witness for an implant manufacturer prior to publication.

This study was not analyzed in the Tufts report.

Reply to Letter: Epidemiology of Scleroderma Among Women: Assessment of risk from exposure to silicone and silica. (Lacey et al 1997)67

This study of 189 Ohio women with scleroderma and 1, 043 healthy women was briefly described in a letter to the editor in the Journal of Rheumatology. It was not peer-reviewed, which is why this is one of the 5 studies included in the meta-analysis that were not included in the IOM report. In a telephone interview, researchers asked women who were diagnosed with scleroderma about their exposure to silicone (including silicone gel breast implants) and compared the likelihood with similarly aged controls. One case and 10 controls reported having silicone breast implants. In addition to the information about implants being unverified and the lack of information about the study design and analysis, this study lacks the statistical power to determine if women with scleroderma are more likely to have breast implants.

This study was not analyzed in the IOM report or Tufts report.

The Association Between Silicone Exposure and Undifferentiated Connective Tissue Disease Among Women in Michigan and Ohio (Laing et al. 1996)68

The results of this study of 206 women with undifferentiated connective tissue disease and 2,239 controls.  In a telephone interview, researchers asked women with undifferentiated connective-tissue disease about their silicone exposure and compared the exposure with similarly aged controls.  The authors state that women with undifferentiated connective-tissue disease were significantly more likely to report having all types of implanted devices, including breast implants, artificial joints, pacemakers, and non-CNS shunts.  Although women with scleroderma were 127% more likely to report having breast implants, that specific difference was not statistically significant.  These results were reported on a non-peer-reviewed abstract from a conference.

This study was funded by Dow Corning.

This study was not analyzed in the IOM report or Tufts report.

Breast Silicone Implants and Risk of Systemic Lupus Erythematosus (Strom et al. 1994)69

The very small study based on phone interviews with 133 Philadelphia women with lupus and 100 friends of those patients included only one lupus patient with implants and none among their friends.  The authors then compared the lupus women to a control group from another study and reported an odds ratio of 4.5 (a 450% increase).  However, the results are meaningless because the study lacked statistical power.

This study was not analyzed in the Tufts report.

A Population-Based Case-Control Study of Risk Factors for Connective Tissue Diseases (Teel et al. 1997)70

This non-peer-reviewed doctoral dissertation included 427 Washington state women with connective tissue diseases and 1,577 other women matched on age and race.  Only 6 of the 427 women had breast implants and there was no statistically significant difference in this study, which was too small to draw conclusions. No information about the study design is publicly available.

This study was not analyzed in the IOM report or Tufts report.

Silicone Breast Implants and the Risk of Fibromyalgia and Rheumatoid Arthritis (Wolfe et al. 1995)71

This study was described in a non-peer-reviewed abstract from a conference. It compared 533 Kansas patients with fibromyalgia and 637 with rheumatoid arthritis to 479 with osteoarthritis and 655 women randomly selected from the general population and statistically adjusted for age. Only 14 women reported having breast implants, the differences were not statistically significant, and the study lacked statistical power to draw conclusions. The information on whether the women had implants was self-reported and unverified. Patients were asked to fill out questionnaires asking if they had breast implants and the healthy controls were questioned on the telephone.

This study was not analyzed in the IOM report or Tufts report.

Additional Studies in the IOM Report

Of the 17 articles in the IOM report, 15 were also in the NEJM meta-analysis (see above) and two were not.

Both were co-authored by Michael Weisman, who was acknowledged as serving as an expert witness defending implant companies in litigation.  Those two articles are as follows:

Connective-Tissue Disease Following Breast Augmentation: A Preliminary Test of the Human Adjuvant Disease Hypothesis. (Weisman et al, 1988)72

One-third (125) of augmentation patients from a private practice agreed to participate in a study based on a survey asking about health-related issues since the surgery, including joint pain or lupus.  There was no control group.  All 38 women who replied “yes” were interviewed on the phone; 16 were thought to have a localized condition.  Only the 22 who were thought to have a systemic inflammatory disease were asked and agreed to a medical visit.  Three were diagnoses with fibromyalgia and since none were diagnosed with classic RA, lupus, scleroderma, or other CTDs, the authors concluded that there is no evidence that implants cause CTD.  However, they acknowledge that the study was too small to conclusively identify a 10-fold or even 100-fold increase of rare diseases such as scleroderma.

Breast Implants in Patients with Differentiated and Undifferentiated Connective Tissue Disease (Williams et al, 1997)73

Of 410 patients enrolled in a study of patients with early-onset CTD, 323 were women.  Most have had signs and symptoms that satisfied criteria for RA, lupus, scleroderma, or polymyositis/dermatomyositis (PM//DM).  The rest had undifferentiated disease.  Women were asked if they had breast implants; only 3 reported having breast implants, 2 of which were prior to CTD.  The authors admit several shortcomings of the study and also conclude that due to the lack of statistical power of this study, it could not identify any increase in CTD due to implants that was under 300%.

Neither of these two articles was included in the Tufts analysis.

Additional Studies from the 2016 Tufts Report Prepared with FDA Guidance

When the FDA determined that the 10-year studies they had required of Mentor and Inamed had lost between 50-80% of the patients in just the first few years, it became clear that there was no point in completing them.  The FDA apparently decided to instead rely on a systematic review funded by the Plastic Surgery Foundation, which was in turn funded by the three-major breast implant manufacturers and written by scientists from Tufts’ Medical Center.53  The report’s Advisory Board included representatives from the implant manufacturers,  plastic surgeons, and the FDA; the one women’s health advocate was a non-scientist whose organization has received funding from implant manufacturers.

Like the IOM report and NEJM meta-analysis, this systematic review relies on industry-funded studies with substantial flaws.  And while the report specifies when the studies do not have the statistical power to adequately determine if implants are associated with diseases or symptoms, the Tufts review fails to focus on other major flaws of the studies it includes it is analysis:

  • Studies that include women with implants for too short a period of time to develop a diagnosed disease. At least 6 of the 22 studies summarized above and 3 of the studies summarized below included women who had implants for a year or less.  Even when some of the women had implants for 5 years or more, it would be important to specify how many had implants for a period that is too short to develop a diagnosable disease.  Nowhere in the 390-page report or the published summary is that shortcoming mentioned.  Similarly, studies that relied on hospitalization for autoimmune or CTD diseases should not have been considered, since few women are hospitalized for CTD unless they have had the disease for a long time.
  • The number of years that women were “followed” was misreported. For the Mentor and Allergan studies, for example, the Tufts report noted that women had been followed for 9 years.  However, as previously noted, three out of four patients had dropped out long before 9 years, making an analysis of 9-year data meaningless.  In fact, most Mentor patients dropped out within 3 years.  The high drop-out rate was never mentioned by the Tufts researchers, and those studies were included in the analysis with no caveats about that major shortcoming.

Their analysis of 32 studies and over 50 publications rely on many studies that conclude that there is no evidence that implants cause CTD or autoimmune diseases, despite clear caveats that the studies have design flaws that make it impossible to draw conclusions about the link between implants and the symptoms that so many women with implants have been reporting.

A closer look at the 2016 review analysis reveals that despite having numerous studies showing a statistically significant risk of rheumatoid arthritis, lupus, Sjögren syndrome, Raynaud’s syndrome, and fibromyalgia among women with breast implants, the authors downplay this association. The authors conclude that there is inconclusive evidence to make a claim between breast implants and long-term health outcomes.

The nine published studies that we reviewed because of their inclusion in the IOM and NEJM analyses include very old studies by Burns et al, 1996,54 Edworthy et al, 1998,55 Friis et al, 1997,50 Gabriel et al, 1994,56 Giltay et al, 1994,57 Nyrén et al, 1998,51 Park et al, 1998,58 Schusterman et al, 1993,59 and Wells et al, 1994.60  Since we have critiqued the problems with these studies above, we will not do so again here.

Below we will analyze the quality of the data of the other 12 studies of autoimmune and CTD symptoms or diseases that were included in the 2016 review from the past two decades, we see a similar pattern in terms of bias and poorly modeled study design. Looking more closely at the newer studies that focused exclusively on CTD and autoimmune disorders, it is apparent that the report relied on a small number of studies in addition to the older studies mentioned above, and that those studies had inconsistent findings.   They include Berner et al 2002,74 Breiting et al 2004,25 Brinton et al 2004,44 Collado Delfa et al 1998,75 Fryzek et al 2001,76 Fryzek et al 2007,77 Kjøller et al 2004,78 Laing et al 2001,79 Lee et al 2011,80 Mentor post approval study,81 Oberto et al 1993,82 Rubin et al 2010.83

Comparative Examination of Complaints of Patients with Breast-Cancer With and Without Silicone Implants (Berner et al, 2002)74

This study compared 32 mastectomy patients with breast implants to 1,100 mastectomy patients without implants. Reconstruction patients were more likely to undergo radiation; most women in both groups did not take hormone treatment. The women completed questionnaires that asked about symptoms such as swelling, general pain, muscle pain, joint pain, numbness or tingling sensations in extremities, or dry eyes.  The women had implants for an average of almost 7 years.  Women with implants had statistically significant increases in fatigue (41% vs. 25%), insomnia (47% to 38%), depression (34% to 20%), numbness/tingling (59% vs. 38%) and swelling of fingers (31% vs. 13%).  The authors noted that these were symptoms rather than diagnosed diseases and were not able to categorize the symptoms as a diagnosis for any classic connective tissue disorders and therefore concluded that middle aged women have the types of symptoms evaluated whether or not they have breast implants.  This study was funded by Dow Corning.

Long-Term Health Status of Danish Women with Silicone Breast Implants (Breiting et al 2004)25

This study compared 190 Danish women with breast augmentation to 186 women with breast reduction and 149 women from the general population. The women had implants for an average of 19 years, according to their medical records.  The women underwent a clinical exam, had a blood test, and completed a questionnaire regarding weight and height, health habits, medication use, and symptoms and diseases such as allergies, hypertension, anemia, cancer, diabetes, connective tissue disorders, breast pain, cognitive symptoms, joint pain, muscle pain, skin rash, and hair loss.  The researchers adjusted for BMI, smoking, alcohol, education, marital status, parity and age at first pregnancy.

Relative risk analysis indicated that women with more than two sets of breast implants had a 2-fold increased risk in cognitive symptoms, 4-fold increased risk of Raynaud-type symptoms, 3-fold increased risk of fatigue, a 6-fold increased risk for antidepressant use and a 6.6-fold increased use of sedatives compared to women in the general population.  Despite the dramatic and sometimes statistically significant differences for women with implants, the researchers conclude that, other than breast pain and capsular contracture, long-term use of silicone breast implants are not related to “other symptoms, diseases, or autoimmune reactivity.”  They also conclude that the excess use of medications for depression and anxiety “may warrant further investigation.”

This study was funded by Dow Corning.

Risk of Connective Tissue Disorders Among Breast Implant Patients. (Brinton et al 2004)44

This study compared 10,778 American women who underwent breast augmentation to 3,214 women who had other types of cosmetic surgery. The women completed questionnaires that asked about autoimmune diagnoses such as rheumatoid arthritis, scleroderma, lupus, Sjögren syndrome, other arthritis, Raynauds, fibromyalgia, vasculitis, chronic fatigue syndrome, and MS.  All augmentation patients had implants for more than 20 years. The researchers reported that 5% of augmentation patients and 3% of the other cosmetic surgery patients reported a diagnosis of at least one of four major CTDs (rheumatoid arthritis, scleroderma, systemic lupus erythematosus, or Sjögren’s syndrome). They reported a statistically significant 100% increase for women with breast implants for scleroderma, Sjögrens, and RA combined an increase as well 30% increased for RA alone.

The Prevalence of Systemic Autoimmune Diseases in Women Reconstructed with Silicone Breast Implants after Mastectomy. A Comparative Study(Collado et al 1998)75

This study compared 81 mastectomy patients reconstructed with silicone breast implants with 72 women reconstructed with autologous tissue or who did not have reconstruction (N = 72). The average period of exposure to silicone was 4.4 years. A medical history, physical examination, general laboratory tests, level of antinuclear antibodies, antithyroid antibodies, and rheumatoid factor were performed on each woman. In no case was connective tissue disease recognized, and the prevalence of the autoantibodies studied did not differ significantly between the two groups. As noted earlier, the follow-up of 4.4 years may have been too short and the number of women with implants was too small to provide definitive results.

Self-Reported Symptoms Among Women After Cosmetic Breast Implant and Breast Reduction Surgery (Fryzek et al 2001)76

This study compared 1,546 Swedish women who underwent breast augmentation with allopathic breast implants to 2,496 women who had breast reduction surgery.  Women who had connective tissue disease or cancer prior to surgery were excluded.  The women completed questionnaires that asked about symptoms such as painful or swollen joints, burning eyes, mouth ulcers, muscle pain, tingling numbness, skin abnormalities, memory difficulties, hair loss, and unexplained fevers.  All augmentation patients had implants for at least one year and ranging up to more than 18 years.  Despite showing statistically significant increases in the reporting of 16 of the 28 symptoms by women with breast implants, and nonsignificant increases in most of the other symptoms, the authors concluded there is no relationship between the symptoms and breast implants because the symptoms did not vary according to “dose response” — the type, size, or number of years the women had implants.

This study was funded by Dow Corning.

A Nationwide Study of Connective Tissue Disease and Other Rheumatic Conditions Among Danish Women with Long-Term Cosmetic Breast Implantation (Fryzek et al, 2007)77        

This study is a 5-year extension of a previously published study (Kjoller et al 2001) and compares 2,761 Danish augmentation patients with 8,807 women who underwent breast reduction and other types of cosmetic surgeries, and also compares with general population data.  The women completed questionnaires that asked about polymyositis, lupus, scleroderma, and Sjögren syndrome, and reported diagnoses were verified in medical records.  Augmentation patients had implants for at least one year and for an average of 13.4 years.  Compared to the general population, they reported a statistically significant 90% increase in the reporting of “unspecified rheumatism” (fibromyalgia symptoms) among women with breast implants and a significant 50% increase among other cosmetic surgery patients.  They also reported nonsignificant increases in RA, polymyositis, scleroderma, Sjögren’s, and fibromyalgia. The authors conclude that there is no association between breast implants and connective tissues diseases.

This study was funded by Dow Corning.

Self-Reported Musculoskeletal Symptoms Among Danish Women with Cosmetic Breast Implants. (Kjøller et al 2004)78

This study compared 688 Danish women who underwent breast augmentation to 688 other cosmetic surgery patients of the same age from the same clinics, and 400 women from the general population. The women completed questionnaires that asked about symptoms that had lasted for at least 3 months since surgery, such as joint pain, muscle pain or weakness, abnormal skin tightness, or dry eyes.  The implanted women had their implants for 0-24 months.  Women with breast implants were more than twice as likely to report joint stiffness and finger swelling; these were statistically significant.  Other symptoms were non-significantly higher or lower for women with breast implants.  The women had implants for such a short period of time that any CTD or autoimmune symptoms would not be expected, and these results cannot be considered conclusive.  However, the authors concluded that mild, moderate and severe rheumatic symptoms were less likely for women with breast implants compared to other cosmetic surgery patients.

This study was funded by Dow Corning.

Women’s Health After Plastic Surgery (Englert et al, 2001)84

This study compared 458 Australian women who underwent breast augmentation to 687 women who had other kinds of cosmetic surgery such as abdominoplasty and rhinoplasty.  The women completed questionnaires that asked about past surgical history, complications, and their subjective ranking of the influence of surgery on their health and body image.  All women underwent a standardized clinical examination, as well as lab tests that were used to validate their self-reports.  All augmentation patients had implants for at least 12-15 years.  Women with implants were three times as likely to report rheumatoid arthritis developing in the years after surgery, but this difference is not statistically significant.

This study was funded by Dow Corning.

Potential Risk Factors for Undifferentiated Connective Tissue Disease among Women: Implanted Medical Devices (Laing et al, 2001)79

This study compared 205 Midwestern women who had undifferentiated CTD and 2,095 randomly selected women without CTD to compare the percentage with breast implants or other types of implants.  The women completed questionnaires that asked about Raynauds phenomenon, Sjögren syndrome, and joint pain.  Duration of breast implantation was not mentioned.  The researchers reported a statistically significant almost 3-fold increase in any type of silicone implants among women with CTD compared to the general population; the 2-fold increase in breast implants was not statistically significant.  However, the CTD women also were more likely to have implants made without silicone, such as orthopedic screws.  When the researchers replicated the study replacing undifferentiated CTD patients with 600 scleroderma patients, the increase in all types of implants, including those made without silicone, remained statistically significant for women with scleroderma.

This study was funded by Dow Corning.

Prospective Cohort Study of Breast Implants and the Risk of Connective-Tissue Diseases (Lee et al, 2011)80       

This study started with 3,950 American women with breast implants and 19,897 without.  All had participated in the Women’s Health Study.  Women with implants completed an additional questionnaire that asked about their implants, reporting that they had implants for a median of 17 years.  All women who had reported a CTD in the Women’s Health Study were asked to complete another questionnaire focused on CTD, and that was completed by 91 women with breast implants and 287 women without breast implants.  The researchers reported statistically significant increases in 3 CTDs for women with implants: a doubling (RR=2.23) in self-reported Sjögren’s syndrome, quadrupling in dermatomyositis/polymyositis, and a 76% increase in “other CTDs.”  Women with implants were also more than twice as likely to report lupus, but that was not statistically significant.  Efforts were made to confirm diagnoses using medical records, but that was not always possible.  The researchers concluded that the data helped “exclude the likelihood of large increases in CTD risk associated with breast implants.”

This study was funded by Dow Corning.

Mentor Summary Basis of Decision (SBD) for Mentor MemoryGel CPG Breast Implants Cohesive III.  Health Canada 2104.85

This report of Mentor data that the company submitted to Health Canada is based on a 10-year study of more than 41,000 augmentation, reconstruction, and revision patients with silicone gel breast implants.  The 7-year follow-up data are provided but they do not mention that most of the women dropped out of the study prior to 7 years (80% drop-out according to other published sources).  The report found a more than 6-fold increase in Sjogren’s syndrome, more than 3-fold increase in scleroderma, 56% increase in Rheumatoid arthritis, 43% increase in lupus. and 18% increase in fibromyalgia.  The increases in Sjogren’s syndrome, scleroderma, and Rheumatoid arthritis were statistically significant.  However, not all the diagnoses were confirmed, and limited information is available from this unpublished report.

Connecttiviti autoimmuni e protesi mammarie: studio controllato sulle nostre pazienti sottoposte (Oberto et al 1993)79

This study included 102 mastectomy patients reconstructed with breast implants compared to 102 mastectomy patients without breast implants. They determined which women had confirmed diagnoses of Raynaud’s syndrome and rheumatoid arthritis. This small study included no women with Raynaud’s in either the implant or non-implant group and two women with rheumatoid arthritis in each group.  This study was too small to draw conclusions about the impact of implants on these two diseases.

Health Characteristics of Postmenopausal Women with Breast Implants (Rubin et al 2010)83

The women in this observational study were from the Women’s Health Initiative observational study, conducted from 1993-98.  Most of the 1,257 augmentation patients in the study had implant surgery more than 20 years prior to the study and they were compared to 86,686 women who did not have breast implant surgery.  Women with a history of breast cancer were excluded.  The women with implants had lower BMI and tended to be more physically active and healthier in terms of diabetes, heart disease, or cataracts; however, they were significantly likely to report a poorer emotional well-being and quality of life.  They were more than twice as likely to have lupus (1.2% vs. 0.5%) but it was unknown if lupus preceded implants or developed after implants, and the diagnosis was not necessarily confirmed in medical records.  Women with implants also reported higher depression scores and more likely to commit suicide (7% of deaths of women with implants compared to 0.4% in the control group.

In summary, the Tufts review relied heavily on industry-funded and plastic-surgery authored studies, many with substantial flaws. Although it included several studies indicating significant increases in autoimmune or CTD symptoms or diseases, the authors concluded that the evidence from those studies was outweighed by the studies that did not find a statistically significant association.  The Tufts report stated that “For none of the outcomes was there sufficient evidence of an association” with breast implants.52  So although the report did not conclude that there was no evidence of an association, it downplayed the evidence that supported an association. It is important to note, however, that when the authors published a summary in a peer-reviewed medical journal, they sounded more open-minded, concluding that “the evidence remains inconclusive about any association between silicone gel breast implants and long-term health outcomes.  Better evidence is needed.”53

Conclusions

Despite the controversies about autoimmune and CTD diseases, the evidence is quite consistent; women with implants tend to have increases in symptoms and diagnoses compared to similar women in the general population.  Although the strength of these associations vary greatly, mostly between 22%-800%, that is not surprising given the differences in which diseases are studied and how they are studied. When patient-reported symptoms are evaluated rather than classic diagnoses, when studies with large numbers of women with implants for 7 years or more are included, and when women with implants are compared to similar women who did not have breast surgery or other types of implants, the associations tend to be stronger and statistically significant.

In order for patients to make informed decisions and the FDA to make policy decisions regarding the regulation and use of breast implants, we need objective studies undertaken by unbiased research teams. All studies have limitations, and studies that start with small numbers of patients, that include women with implants for too short period of time, or where most patients drop out (for whatever reason) before long-term data are collected are especially inadequate to evaluate the impact of implants on systemic diseases, whether cancer, autoimmune, or connective tissue diseases.  The FDA is now emphasizing the use of device registries to provide post-market data on patients with breast implants and other types of implants, but device registries are focused on counting the number of surgeries rather than evaluating symptoms or other complications.  The focus on surgeries and revision surgeries omits many of the outcomes that matter most to patients, and especially patients who may not have the financial resources to undergo additional surgeries.  Instead, studies are needed of women with breast implants for at least 10 years, compared to similar women who did not undergo any type of breast surgery, evaluated in terms of specific autoimmune symptoms that the women are reporting when they say they have “breast implant illness.”

 

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Breast Implant Injuries Hidden As Patient’s Questions Mount

Meghan Hoyer, AP News: November 26, 2018.

WASHINGTON (AP) — To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year.

Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA’s system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018.

Suddenly, women like Jamee Cook had evidence suggesting their suffering might be linked to their breast implants. An emergency room paramedic, Cook had quit her job because of a vague but persistent array of health problems that stretched over a decade, including exhaustion, migraines, trouble focusing and an autoimmune disorder diagnosis.

Why had it taken so long for complaints like hers to see the light of day?

Makers of breast implants were required to track patients and their health. But for more than a decade, manufacturers with high numbers of recurring problems — in the case of implants, ruptures that required surgery to remove — were allowed to report issues in bulk, with one report standing in for thousands of individual cases and no way for the public to discern the true volume of incidents.

That agreement stood even as the FDA began closely monitoring a rare type of cancer and acknowledged in 2011 that it might be linked to breast implants.

“It looked like these devices had become safer, but they hadn’t,” Cook told The Associated Press. “The data was hidden. It’s a deceptive practice.”

Once Cook’s textured saline implants were removed, she said the majority of her symptoms disappeared. Her experiences prompted her to become a patient safety advocate, lobbying lawmakers and organizing groups of women online who have concerns about breast implants.

Public health advocates who’ve watched the debate over breast implant safety rage for nearly three decades say summary reporting is yet another way that information about the devices has been elusive for patients.

“They were told those devices were safe — the FDA would go back and say ‘We only have this many reports,’” said Madris Tomes, a former FDA staffer who founded a company to analyze medical device reports. “But data was coming in another way that wasn’t public. It leaves the patients demoralized — they don’t understand how many other people are suffering.”

The data came to light after the FDA instructed manufacturers in mid-2017 to go back and file individual reports in each case of patient injury, in response to a lawyer’s discovery that reports from his clients weren’t represented in the agency’s data. Patient advocates took up the issue, complaining about a lack of transparency and voicing concerns about a host of autoimmune problems they believed stemmed from their implants.

But even as the FDA was dealing with the problems of how breast implant manufacturers had used summary reporting, the agency was moving to expand device makers’ flexibility in how they report problems, saying it was trying to reduce the industry’s paperwork requirements.

This August, the agency began allowing roughly 90 percent of all medical devices — including all breast implants and more than 160 types of other high-risk implanted devices like artificial hips and replacement heart valves — to report malfunctions in a quarterly tally, instead of individually. They will not be able to report cases involving deaths or injuries that way, however.

The FDA rejected claims that expanding summary reporting could harm public health by making problems with devices less transparent, saying the plan “will also yield benefits . such as helping FDA process malfunction reports more efficiently and helping both FDA and the public more readily identify malfunction trends.”

FDA officials also said that the agency has closely monitored the breast implant industry in the past decade and issued updates about potential risks.

Two of the largest breast implant manufacturers, Mentor and Allergan, said they stood behind the safety of their products, citing years of studies that have led to inconclusive evidence that autoimmune problems are linked to breast implants.

“Our medical devices undergo extensive laboratory testing before they are submitted to government health experts for a science-based review,” Mentor spokeswoman Mindy Tinsley said. “Many of our devices undergo careful reviews by not just one, but multiple regulatory bodies around the world.”

Still, it can be hard for breast implant patients and advocates to track problems that do arise.

Insurance claims make no mention of the specific device or model implanted in a patient, and patients’ electronic health records aren’t required to record that either. In addition, products sold overseas can be renamed or carry a different model number, making international recalls or tracking across borders nearly impossible.

Meanwhile, the FDA’s main database on medical device problems, which requires manufacturers to report patient deaths and serious injuries to the government within 30 days, relies on hand-typed entries from a variety of people — from patients to device manufacturers — to help track troubled products. That can lead to underreporting, along with missing and flawed data.

Tomes said accurate, complete and publicly accessible data is crucial to identifying problems quickly and making sure devices are safe. The FDA numbers, she said, offer the lowest possible count of reports about problems with breast implants.

“You can assume that the numbers are probably much, much higher,” she said.

A Duke University report funded by the FDA in 2016 found that even though the agency collected data on device malfunctions for more than two decades, “reliably and efficiently tracking the medical device safety and effectiveness outcomes of most interest to patients remains a generally unfulfilled promise” that “significantly affects the public health.”

Insurers, auto buyers and regulators all use a car’s VIN number to track a vehicle’s history, down to the line it was manufactured on at a specific factory, and the FDA’s own pharmaceutical drug oversight works similarly. But medical devices didn’t have a similar unique identifier until 2015, and many of the least-risky devices won’t put an ID into use until 2020. On top of that, experts say it could be years before their use is required in patient records, on insurance claims and in the FDA’s own data.

What are the most common makes and models of breast implants reported as having caused injury? The FDA’s answer is still quite often “Unknown.”

___

The FDA requires manufacturers and medical facilities to file a report when any kind of medical device causes serious injury, death or malfunctions.

The resulting database — called MAUDE, for Manufacturer and User Facility Device Experience — is available online to the public, so consumers can search for a device type, manufacturer, the details of an incident and the date on which it occurred. That is, if the forms are filled out properly.

But categories often are left blank, with no indication of the model or who submitted the report. And device names and manufacturers also are often misspelled, making it nearly impossible for users to find all the reports of problems with a specific device or company. For example, the data contains roughly 2,000 variations of the name Medtronic plc, one of the world’s largest medical device manufacturers.

Overall, the MAUDE data contains reports of more than 1.7 million injuries and nearly 83,000 deaths over the past 10 years for all types of medical devices, according to an analysis of FDA data by the International Consortium of Investigative Journalists, which collaborated with the AP on a global investigation of medical device safety.

But in looking at problems with the MAUDE data, the investigation found an additional 2,100 cases in the past five years where people died but their deaths were misclassified as “malfunctions” or “injuries.” Of those, 220 deaths could be directly linked to medical device failure; the other reports did not include enough information to determine conclusively if the device played a role.

Beyond the misclassified data, FDA inspections at 17 hospitals in 2015 and 2016 found that only a fraction of “adverse events” were even being reported anyway. The review —which included major facilities in Los Angeles, New York, Boston and Chicago — found more than half failed to report deaths of patients with medical devices, as required by the agency’s rules. Jeffrey Shuren, the head of the FDA’s device division, said at the time that underreporting problems from hospitals was widespread. The agency enhanced compliance training for hospital employees nationwide as a result.

Part of the problem, advocates say, is that the FDA’s guidelines for reporting problem devices is vague — the agency states that reports are required from manufacturers within 30 days of an event when evidence “reasonably suggests” that a device was involved, allowing companies to make their own judgments.

S. Lori Brown, now a retired FDA senior researcher, used MAUDE for years in her studies of breast implants, ruptures and possible links to rare forms of cancer and a host of autoimmune disorders.

“It’s a difficult database to use, because there’s no good way to confirm what’s reported, and there’s no denominator — you don’t know how many people have received breast implants,” Brown said. “The MAUDE database was just not very helpful in finding out how frequently things happened or how severe the impact was.”

Where it was helpful, she said, was in gathering patient stories and seeing general trends. In the 1990s, even as manufacturers claimed breast implants were durable enough to be run over by a car without breaking, MAUDE showed silicone implants leaking gel into thousands of women’s bodies.

“As a signal, it was a burning bush, for sure,” Brown said. “Because there were so many reports of ruptured implants from every manufacturer.”

After the FDA removed silicone breast implants from the market in 1992, the public attention around ruptures and leaks resulted in a huge spike in the number reports about problems. During the 1990s, silicone implants represented the third-highest number of adverse events reports in MAUDE. At the time, the data show patients also complained about other symptoms, with hundreds of reports about chronic fatigue, headaches, autoimmune problems and fibromyalgia.

In 2006, silicone implants returned to the market, under the requirement that companies track patients for at least a decade. Although more than half the women dropped out of the studies within the first two years, researchers at the University of Texas MD Anderson Cancer Center in Houston released a study this September using the data the companies did collect and found that certain rare health problems — including immune system and connective tissue disorders — might be more common with silicone gel implants. The FDA, which mandated the original data collection, later criticized the study, citing “inconsistencies in the data.”

Last year, the FDA did confirm a link between breast implants, particularly textured saline or silicone models, and anaplastic large cell lymphoma — a rare cancer documented in only a few hundred cases.

On its website, the FDA also noted more common problems with implants, such as ruptures, which can send silicone gel throughout the body. And the agency warned that implants “are not lifetime devices,” but will likely need to be removed or replaced at some point.

The return of silicone implants, which advocates say feel more natural, has fueled a surge in surgeries. The American Society of Plastic Surgeons reported 400,000 procedures took place in 2017, up nearly 40 percent since 2000.

More than three-quarters of the implant surgeries were for cosmetic, not reconstructive, reasons. And there were about 20 percent fewer removals compared to 2000, the data show.

The increase in implants worries Diana Zuckerman, a medical researcher who was a congressional staffer during the earliest contentious House hearings on breast implant safety. She said poorly performed studies, research funded directly by manufacturers and the lack of data have left most women in the dark about the risks involved.

“Somehow, it’s the most studied device and we have almost no useful information about it,” said Zuckerman, the president of the National Center for Health Research, a nonprofit think tank that performs its own research, assesses the quality of others’ research and works with patients.

Zuckerman’s center reviewed more than 20 studies it says has been used by the industry to claim there is no evidence breast implants cause connective tissue problems and other long-term illnesses. She said almost all the studies were too small to detect rare diseases and conditions, only one required that participants have a medical exam and most didn’t focus on patients who had implants long enough for problems to develop.

In September, Cook and 19 other breast implant patients-turned-health-advocates visited Washington to lobby the FDA for more stringent regulation, testing and reporting on breast implants. Among their requests — that all types of textured implants, which are more closely associated with lymphoma, be banned from the market, and that manufacturers be required to disclose the chemicals in silicone implants’ shell and gel filling, which the makers claim is a trade secret.

The FDA has scheduled an advisory committee hearing for early 2019 on breast implant safety to address some of the U.S. group’s concerns and determine whether additional actions are needed to protect public health. The agency did not rule out the possibility of including a “black box warning,” the notification it puts on its most dangerous devices to draw attention to serious risks.

However, the FDA said in a statement: “The agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases.”

Cook, who leads several breast implant groups on Facebook from her home near Dallas, said she chose to get her implants, but did so with almost no information on the potential dangers.

“If you had sat down with me and said ‘this is the list of chemicals you’re about to put in your body and you could get lymphoma,’ no way in hell I would have done it,” she said.

Her implants, a textured saline model made by Poly Implant Prothese of France, were used in the U.S. for four years before the FDA implemented more stringent standards for breast implant approval in 2000. Under the new rules, the FDA denied the company’s application to sell implants in the U.S. after officials toured the company’s French plant and cited 11 major deficiencies in quality control and manufacturing practices.

Poly Implant went bankrupt in 2010 after doctors in France noted abnormally high rupture rates of the implants, which were found to be filled with industrial-grade gel. The company’s president was found guilty of aggravated fraud, and French authorities advised tens of thousands of women to get their implants removed as a precautionary measure.

Cook, 41, said she and others who already had the saline implants never were warned of the FDA’s actions.

“I’m not going to sit back and be embarrassed about my decision when I can try to change the way that the future is going to occur for women younger than me,” she said. “We need to make sure we’re giving that patient the most safe device we possibly can. And above that, we need to make sure she understands what the risks are before she makes that choice.”

___

The FDA may now require an identifying number on medical devices, but Zuckerman and other advocates note one big issue with the code associated with breast implants: The number is not actually stamped on the implant itself, but on the packaging.

“For the most part, these devices don’t cause immediate problems — they cause problems later,” Zuckerman said. “What good does it do to have these numbers if they’re not in your medical records and they aren’t on the implant itself?”

The unique device identifier, or UDI, is intended to help standardize device names and manufacturer information and make it easier to track devices to help in recall efforts and analyses of problems.

But that doesn’t work if the codes aren’t in the FDA’s own database. Tomes, whose company Device Events analyzes MAUDE data, said UDIs are still rarely included in adverse event reports and, even when they are, often are removed from the public data so they can’t be used to identify specific devices.

“The whole point of having a UDI is so that hospitals and providers and insurance companies and anyone else would be able to say ‘I’m seeing a pattern, it’s all this serial number,’” Tomes said. “But it’s redacted.”

Similarly, Tomes and others say the FDA’s expansion of summary reporting and its use of device registries — databases funded and maintained by outside organizations to track a singular specific device — may ultimately make less data available to consumers.

This fall, the agency announced a breast implant registry run through the Plastic Surgery Foundation that will collect patient and device data — including UDI numbers for breast implants — and allow surgeons to track patients’ medical history, complications and follow-up surgeries.

The participation of plastic surgeons in the registry is voluntary, and patients also can opt out. Doctors and researchers will have access to the collected data, but the public will not.

As the FDA weighed its expansion of the summary reporting program earlier this year, Cook and a dozen other patients with medical device problems, along with the patient-advocacy group Public Citizen, urged the agency to rethink its plan.

But the FDA sided with manufacturers and industry organizations, which had asked for easier reporting requirements for malfunctions, freeing them in some cases from filing tens of thousands of individual reports a year. Under the new rules now in place, roughly 90 percent of devices can report malfunctions quarterly.

“Thousands on thousands of consumers are harmed every single year by medical devices and we are discussing making it easier to hide the information that we need to make an informed decision,” Cook wrote in her dissent to the plan.

“While the goal is not to ‘hide’ the data,” she wrote, “in essence that is what is happening.”

Read the original news article here.

Silicone Breast Implants Increase Arthritis Risk 600%, Stillbirth Risk 450% and Skin Cancer Risk 400%, Study Claims

Mary Kekatos, Daily Mail: November 20, 2018.

Silicone implants can increase a woman’s risk of arthritis, stillbirth and even skin cancer, a new study suggests.

Researchers found that women had a 4.5-fold increased risk of having a stillbirth and a four times greater risk of developing melanoma after their procedures.

In comparison with saline implants, women with silicone implants were also two times more likely to have surgical complications, particularly scarring around the implant.

The team, from the University of Texas MD Anderson Cancer Center in Houston, says its study is the largest of breast implant outcomes to date and the findings are important to help women choose the implant they feel is right for them.

The most popular implants approved by the US Food and Drug Administration (FDA) are silicone implants and implants filled with a saline solution.

Silicone implants use shells filled with a plastic gel while saline implants use silicone shells filled with a sterile saline solution.

For breast reconstruction, the rebuilding of a breast, both implants are approved for women of all ages.

For breast augmentation, meant to increase the size or change the shape of a breast, saline implants are approved for women aged 18 or older and silicone implants are approved for women aged 22 or older.

Many women say silicone implants feel more like real breasts than saline implants do, but they pose a greater risk if they leak.

In the early 1990s, the FDA prohibited silicone implants after several health concerns were raised about their association to a risk of cancer, connective tissue disease and autoimmune diseases.

No research established a definitive link between silicone implants and these conditions.

After silicone implants from two manufacturers were approved in 2006, the FDA conducted many postapproval studies, but no researchers had analyzed the database.

For the new study, published in the journal Annals of Surgery, the team looked at nearly 100,000 patients enrolled in large postapproval studies between 2007 and 2010.

Approximately 80,000 had silicone implants and the rest received implants filled with a saline solution.

Additionally, 72 percent of the women had a breast augmentation, 15 percent had a revision augmentation, 10 percent had breast reconstruction, and three percent had revision reconstruction.

Researchers found the women who had silicone implants had a higher risk of several rare adverse outcomes.

This included rheumatoid arthritis; Sjogren’s syndrome, an immune system disorder characterized by dry eyes and dry mouth; and sclerodermia, chronic hardening and tightening of the skin and connective tissues.

All these conditions came with a risk six to eight times higher in these women than in the general population.

Women with silicone implants were also at a 4.5-fold increased risk of having a stillbirth, but not a miscarriage.

Researchers also found that women with silicone implants had a risk of developing melanoma that was four times greater.

Silicone implants were also associated with a higher risk of surgical complications compared to saline solutions.

Around five percent of women had scarring around the implant, known as capsular contracture, compared with 2.8 percent of women with saline implants.

‘We are reporting an analysis of the largest prospective study to date on silicone breast implant safety,’ said Dr Mark Clemens, an associate professor in the department of plastic surgery at MD Anderson Cancer Center.

‘We are sharing critical information on complication rates and rare associations with systemic harms. This data gives women important safety information about silicone breast implants to have real expectations and to help them choose what is right for them.’

The authors noted that although certain risks were more common in women with silicone implants, ‘absolute rates of these adverse outcomes were low’.

‘Women shouldn’t panic but what it does tell us is that there’s something going on and it’s different than what women have been told for the last two decades,’ Dr Diana Zuckerman, President of the National Center for Health Research, told DailyMail.com

‘It’s still cause for concern and you have to think that all those increased risks adds up. Not all women are getting all these diseases but it’s some getting one and some getting another that could be statistically different.’

But Dr Stuart Linder, a plastic surgeon from Beverly Hills, California, is skeptical of the study.

‘I use silicone implants and I have for over 20 year and I haven’t seen anything that has hinted of this,’ he told DailyMail.com.

‘Unless the FDA states the risk is higher, then the products are deemed to be safe and usable in surgery.’

See original article here.

Sample Letter of Medical Necessity

Here is a sample letter of medical necessity written for a woman with ruptured silicone gel implants and severe capsular contracture. For help writing your own letter of medical necessity, contact us at info@breastimplantinfo.orgClick here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

January 5, 2018

XYZ Claims Department
167 Daisy Lane
Milwaukee, OK 12345

RE: Letter of Medical Necessity for Jane Doe

Group/policy number: 1425-2345-1234
Date(s) of service: January 2, 2018

Dear XYZ Claims Department:

I am writing on behalf of Jane Doe, to document medical necessity and request prior-authorization for explantation of two silicone gel breast implants. Ms. Doe is a 56-year-old female with rupture of her right implant, Baker level III capsular contracture in her left implant, and significant pain in both breasts. She has been in my care since September 21, 2017. Ms. Doe requires an explantation with permanent removal of both implants.

As a result of her pain, Ms. Doe has experienced significant deficits in her daily functioning, including not being able to reach above her head, get dressed, or drive to work. She has previously taken a variety of over-the-counter and prescription pain medications, which have not alleviated her pain. The attached medical records document Ms. Doe’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for this patient that is more conservative or less costly.
My patient’s XYZ policy states the following:

“Removal of breast implants that were initially placed for cosmetic purposes is covered when it is considered medically necessary to treat illness or restore the functioning of a body part.”

According to the medical policy of XYZ, Ms. Doe’s breast implant removal should be covered because she has severe capsular contracture that interferes with her daily functioning and has interfered with mammography. Removal of her breast implants and scar tissue surrounding them should relieve her breast pain and eliminate her capsular contracture.

Surgical implant removal is the standard treatment for severe capsular contracture and ruptured silicone-gel breast implants, and this procedure is clinically appropriate for my patient’s condition. Based on the language above, this procedure should be considered medically necessary.

I ask that you take the above information into consideration and offer coverage for Ms. Doe’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at (111) 111-1111 or doctor@iworkhere.org.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s Office Visit Notes from 9/21/2017
MRI Report from 11/10/2017
Ms. Doe’s post-operative report from 1/2/2018